# FDA registered medical device manufacturers: 586, page 2

Updated November 9, 2026.

Manufacturers in Taiwan, 501 to 586 of 586, in the same order as page 1.

## The full lists

This record is a row of these lists. Pay by card with no account. Prices exclude VAT. CSV and Excel files with the columns this page does not show (establishment name, FDA registration number, FEI number, street, city, state and 14 more), which open on your screen as soon as the payment clears and come by email.

- [FDA registered medical device manufacturers in Taiwan](https://specstream.ai/data/medical-devices/country/taiwan): 586 rows, establishments with an active FDA registration in the FDA files exported November 9, 2026, $29.30. Buy: https://specstream.ai/data/medical-devices/country/taiwan
- [FDA registered medical device manufacturers and other establishments](https://specstream.ai/data/medical-devices): 25,781 rows, establishments with an active FDA registration in the FDA files exported November 9, 2026, $337.81, or the new rows each week for $19 a month. Buy: https://specstream.ai/data/medical-devices

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the manufacturers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

## Manufacturers in Taiwan, page 2

| Manufacturer | Location | FDA registration | Device types | 510(k) clearances | PMA approvals | Recall events | Source |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Shineo Technology Co., Ltd. | New Taipei City, Taiwan | 3043503913 | 2 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223043503913%22&limit=1) |
| Shu Gie Industrial Co., Ltd. | Tainan City, Taiwan | 8022547 | 5 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%228022547%22&limit=1) |
| Shun Hsiang Plastic Co.,ltd. | Taoyuan, Taiwan | 3008102163 | 2 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223008102163%22&limit=1) |
| Sigma-Care Development Co., Ltd. | Dalin Township, Chiayi County Chiayi(County), Taiwan | 3003770834 | 6 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223003770834%22&limit=1) |
| Sinbon Electronics Co., Ltd | Miaoli, Taiwan | 3009139884 | 1 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223009139884%22&limit=1) |
| Sino Optical Co., Ltd | New Taipei City, Taiwan | 8043384 | 1 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%228043384%22&limit=1) |
| Smart Hosiery Co., Ltd. | She tou Changhua, Taiwan | 3013563999 | 1 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223013563999%22&limit=1) |
| Snowrex International Co., Ltd. | Taipei, Taiwan | 3013484347 | 1 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223013484347%22&limit=1) |
| Soleetech Corporation | Lujhou Taipei, Taiwan | 3003481016 | 6 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223003481016%22&limit=1) |
| Song Young Intl. Co. | Taipei, Taiwan | 9616704 | 4 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%229616704%22&limit=1) |
| South Canal Intl. Co., Ltd. | Tainan City, Taiwan | 8022755 | 9 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%228022755%22&limit=1) |
| Special Protectors Co., Ltd. | New Taipei City, Taiwan | 9616914 | 19 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%229616914%22&limit=1) |
| Sum Sporting Goods Works | Taichung City 427, Taiwan | 3010173663 | 2 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223010173663%22&limit=1) |
| Sun Festiva Co., Ltd. | Tainan City, Taiwan | 9617488 | 1 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%229617488%22&limit=1) |
| Sun May Industrial Co., Ltd. | Pan Chiao City Taipei, Taiwan | 8022611 | 4 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%228022611%22&limit=1) |
| Sun Sight Glasses Co., Ltd. | Tainan, Taiwan | 8020627 | 6 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%228020627%22&limit=1) |
| Sun Wellen, Inc. | Taipei, Taiwan | 8043173 | 3 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%228043173%22&limit=1) |
| Sun-Shine Land Intl. Ltd. | Tamsui Taipei, Taiwan | 9710514 | 21 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%229710514%22&limit=1) |
| Suncute Industries Co. Ltd. | Taoyuan, Taiwan | 8020623 | 6 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%228020623%22&limit=1) |
| Sundex Optical Co., Ltd | Kaohsiung City, Taiwan | 3014299855 | 3 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223014299855%22&limit=1) |
| Sunever Eyewear Co., Ltd. | Tainan City, Taiwan | 3008675266 | 4 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223008675266%22&limit=1) |
| Sunjoy Enterprises Limited | New Taipei City, Taiwan | 3005651859 | 8 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223005651859%22&limit=1) |
| Sunmax Optical Co., Ltd. | Tainan City, Taiwan | 3008524117 | 2 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223008524117%22&limit=1) |
| Sunshine Optical Co., Ltd. | Tainan, Taiwan | 8020552 | 1 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%228020552%22&limit=1) |
| Shin-I Medical Manufacturing Co. Ltd. | Taoyuan, Taiwan | 1000252066 | 7 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221000252066%22&limit=1) |
| Shummi Enterprise Co., Ltd. | Taipei, Taiwan | 3005816808 | 10 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223005816808%22&limit=1) |
| Star Seeds Co., Ltd | Lu-Kang Changhua, Taiwan | 3013913556 | 1 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223013913556%22&limit=1) |
| Sun Polar International Co., Ltd. | Changhua County, Taiwan | 3008381219 | 7 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223008381219%22&limit=1) |
| T-Link Ppe Ltd | Neihu District, Taipei, Taiwan | 3006748697 | 4 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223006748697%22&limit=1) |
| Ta Lai Sporting Goods Enterprises Co. Ltd. | New Taipei City, Taiwan | 9617045 | 10 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%229617045%22&limit=1) |
| Tahoma Enterprises Inc | Sindian City Taipei, Taiwan | 3009340798 | 5 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223009340798%22&limit=1) |
| Tai-Shiny Technology Co., Ltd. | Guishan District Taoyuan, Taiwan | 3021013132 | 2 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223021013132%22&limit=1) |
| Taicend Technology Co., Ltd | Kaohsiung City, Taiwan | 3015172365 | 9 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223015172365%22&limit=1) |
| Taiwan Advanced Nanotech Inc. | Taoyuan City, Taiwan | 3026035655 | 1 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223026035655%22&limit=1) |
| Taiwan Advanced Nanotech Inc. | Taoyuan City, Taiwan | 3013548521 | 1 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223013548521%22&limit=1) |
| Taiwan Bewelltech Inc. | Taipei City, Taiwan | 3045751458 | 1 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223045751458%22&limit=1) |
| Taiwan Diversitec Manufacturing Corp. | Taoyuan, Taiwan | 3042159556 | 1 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223042159556%22&limit=1) |
| Taiwan Serpro Corporation | Taipei City, Taiwan | 3007728289 | 1 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223007728289%22&limit=1) |
| Taroko Intl. Co., Ltd. | Jen-Te, Tainan, Taiwan | 8022779 | 6 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%228022779%22&limit=1) |
| Tci Gene Inc. | Taipei, Taiwan | 3017305295 | 1 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223017305295%22&limit=1) |
| Teh Lin Prosthetic & Orthopaedic, Inc. | Taipei, Taiwan | 9617046 | 7 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%229617046%22&limit=1) |
| Teh Seng Pharmaceutical MFG. Co., Ltd. | Tainan City, Taiwan | 3003146628 | 1 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223003146628%22&limit=1) |
| Tes Touch Embedded Solutions Inc. Taiwan Branch | Taipei, Taiwan | 3011824402 | 1 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223011824402%22&limit=1) |
| Thames Co., Ltd. | Taipei, Taiwan | 3003268108 | 2 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223003268108%22&limit=1) |
| Three Leaves Industrial Co., Ltd. | Taipei, Taiwan | 8022542 | 4 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%228022542%22&limit=1) |
| Three Star Co., Ltd. | Tainan City, Taiwan | 9615561 | 5 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%229615561%22&limit=1) |
| Tien Jiang Enterprise Co., Ltd. | Tainan City, Taiwan | 3003849847 | 23 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223003849847%22&limit=1) |
| Tien Rong Hsing Optical. Co., Ltd | Tainan, Taiwan | 3003155376 | 1 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223003155376%22&limit=1) |
| Tomocross International Co., Ltd | Taichung City, Taiwan | 3020977243 | 1 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223020977243%22&limit=1) |
| Tonshung Technology Co.,ltd. | Tainan City, Taiwan | 3014273526 | 3 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223014273526%22&limit=1) |
| Top Longmax Products Co., Ltd. | Taichung, Taiwan | 3003772414 | 19 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223003772414%22&limit=1) |
| Top Medical Corp. | Chung Li City Taoyuan, Taiwan | 3007127364 | 7 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223007127364%22&limit=1) |
| Trimax Safety Corp. | TAINAN City, Taiwan | 3006573171 | 4 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223006573171%22&limit=1) |
| Tronjen Medical Technology Inc | Nantun Dist. Taichung, Taiwan | 9616572 | 9 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%229616572%22&limit=1) |
| Tsair Yuarn Industrial Co., Ltd. | Tainan City, Taiwan | 3003616231 | 5 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223003616231%22&limit=1) |
| Tsarn Shyan Fa Enterprise Co., Ltd. | RENDE DIST. Tainan, Taiwan | 3003902969 | 2 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223003902969%22&limit=1) |
| TST Biomedical Electronics Co., Ltd. | Taoyuan, Taiwan | 3023197868 | 7 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223023197868%22&limit=1) |
| TZY Shenq Enterprise, Co., Ltd | Taichung, Taiwan | 3003384232 | 2 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223003384232%22&limit=1) |
| Technical Services for Electronics, Inc. | New Taipei City, Taiwan | 3008483389 | 51 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223008483389%22&limit=1) |
| Teh Sen Technology Inc. | New Taipei City,, Taiwan | 3006899173 | 2 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223006899173%22&limit=1) |
| Trividia Health Taiwan, INC. | HSINCHU CITY Hsinchu(City), Taiwan | 9612841 | 2 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%229612841%22&limit=1) |
| Tsung Hau Technology Co., Ltd. | Kaohsiung City, Taiwan | 3012444083 | 2 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223012444083%22&limit=1) |
| U-Join Company Limited | Yuanlin City Changhua, Taiwan | 3009387162 | 4 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223009387162%22&limit=1) |
| Ulife Healthcare Inc. | Taoyuan City, Taiwan | 3014615038 | 2 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223014615038%22&limit=1) |
| Unident Enterprise Co | Tainan City, Taiwan | 3006497665 | 1 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223006497665%22&limit=1) |
| Unipack Equipment Co., Ltd | Kaohsiung City, Taiwan | 3042158576 | 2 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223042158576%22&limit=1) |
| Unique Safety Equipment Co., Ltd. | New Taipei City, Taiwan | 3012903018 | 2 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223012903018%22&limit=1) |
| Valiente Co.,ltd. | Taipei, Taiwan | 8022554 | 2 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%228022554%22&limit=1) |
| Vitaltec Corporation | Hou Li District Taichung, Taiwan | 3003851906 | 3 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223003851906%22&limit=1) |
| Volar International Co., Ltd. | Tainan City, Taiwan | 3017820141 | 4 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223017820141%22&limit=1) |
| WCC BIOMEDICAL Co., Ltd | Hsinchu City Hsinchu(City), Taiwan | 3027498673 | 1 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223027498673%22&limit=1) |
| Well Sun Optical Technology Limited. | Tainan, Taiwan | 3011164728 | 7 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223011164728%22&limit=1) |
| Wellgen Medical Co., Ltd | Kaohsiung City, Taiwan | 3031601656 | 2 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223031601656%22&limit=1) |
| Welltex Sports Co., Ltd. | Taipei City, Taiwan | 3014672091 | 23 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223014672091%22&limit=1) |
| Wheelstone Enterprise Co., Ltd. | Taichung City, Taiwan | 3014146184 | 1 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223014146184%22&limit=1) |
| Wholecare Biomedical Corporation | Taipei City, Taiwan | 3009507357 | 1 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223009507357%22&limit=1) |
| Wistron Medical Technology Corporation | Zhubei City Hsinchu(County), Taiwan | 3008460104 | 4 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223008460104%22&limit=1) |
| Y.M.K. International Co., Ltd. | TAIPEI New Taipei, Taiwan | 8022787 | 10 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%228022787%22&limit=1) |
| Yankang Medical Instrument Co., Ltd. | Taipei, Taiwan | 3039346136 | 8 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223039346136%22&limit=1) |
| Yasco Enterprise Corp. | Chiayi County Chiayi(County), Taiwan | 3003902312 | 33 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223003902312%22&limit=1) |
| Yi Yi Transworld Corp. | Taichung City, Taiwan | 3036716847 | 1 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223036716847%22&limit=1) |
| Yong Tai Global Co., Ltd. | Tainan City, Taiwan | 3015134013 | 6 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223015134013%22&limit=1) |
| Yuea Tay Industrial Co Ltd | Taichung City, Taiwan | 3008489100 | 1 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223008489100%22&limit=1) |
| Yuh Jaan Industrial Co., Ltd. | Taichung City, Taiwan | 3034209804 | 1 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223034209804%22&limit=1) |
| Yuh Shiuans Co., Ltd. | New Taipei, Taiwan | 3004102039 | 3 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223004102039%22&limit=1) |
| Youwon Enterprises Co., Ltd | Taipei, Taiwan | 3002824588 | 1 | 0 | 0 | 0 | [api.fda.gov](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223002824588%22&limit=1) |

- [Previous page](https://specstream.ai/data/medical-devices/country/taiwan)

Source: [openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files)](https://open.fda.gov/data/downloads/). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. FDA registration lists an establishment with the FDA and is not an approval of it: a 510(k) clearance or a PMA approval is for one device.

Free to reuse with credit to SpecStream under [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/).