Data / Medical devices / Container, Specimen Mailer And Storage, Non-Sterile
Container, Specimen Mailer And Storage, Non-Sterile (NNK): 144 FDA-registered makers in 23 countries
144 establishments in 23 countries are registered with the FDA to make Container, Specimen Mailer And Storage, Non-Sterile (product code NNK, Class 1, 21 CFR 864.3250). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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 makers 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.
- Product code
- NNK
- Device class
- 1
- Regulation
- 864.3250
- Medical specialty
- Pathology
Makers by country
| Country | Makers |
|---|---|
| United States | 48 |
| China | 45 |
| Canada | 9 |
| Germany | 7 |
| Vietnam | 7 |
| United Kingdom | 4 |
| Taiwan | 4 |
| Netherlands | 2 |
| South Korea | 2 |
| Austria | 2 |
| India | 2 |
| Sweden | 1 |
| Switzerland | 1 |
| Italy | 1 |
| Myanmar | 1 |
| Denmark | 1 |
| Malaysia | 1 |
| Cambodia | 1 |
| Thailand | 1 |
| Ireland | 1 |
| Slovakia | 1 |
| Australia | 1 |
| Turkey | 1 |
Makers of Container, Specimen Mailer And Storage, Non-Sterile
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Aero-Med LLC | East Hartford, CT, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ahlstrom Germany GMBH | Barenstein Saxony, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alom Technologies Corporation | Fremont, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ALOM Technologies Corporation | Indianapolis, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Advance Dx, Inc. | Scottsdale, AZ, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Agendia Inc | Irvine, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Agendia NV | Amsterdam Noord-Holland, Netherlands | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alltrista Plastics LLC | Reedsville, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| American Laboratory Products Company | Salem, NH, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bach Viet Plastic | Ho Chi Minh city, Vietnam | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biosys Laboratories, Inc. | S Pasadena, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boen Healthcare Co., Ltd. | Suzhou Jiangsu, China | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Capitainer AB | Solna Stockholm, Sweden | Complaint file establishment, Exporter to the US, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cellpath Ltd | NEWTOWN Powys, United Kingdom | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changzhou DSB Medical Co., Ltd | Changzhou City Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Chematics, Inc. | North Webster, IN, United States | Complaint file establishment, Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CITOTEST Labware Manufacturing CO., LTD. | Haimen Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Citotest Scientific Co.,ltd. | Nanjing Jiangsu, China | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Color Diagnostics, LLC | South San Francisco, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Covaris, LLC | Woburn, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CalibreScientific US, Inc. | Vancouver, WA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dalian Rongbang Medical Healthy Devices Co Ltd | Dalian Liaoning, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DBS System S.A | Gland Vaud, Switzerland | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diapath S.P.A. | Martinengo Bergamo, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diatrust Medical Co., Ltd. | Nanjing City Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dieu Thuong Joint Stock Company | Tam Phuoc Ward Dong Nai, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dignity Care Network | Retford Nottinghamshire, United Kingdom | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dna Genotek, Inc. | Ottawa Ontario, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Double Packing (myanmar) Co Ltd | Yangon, Myanmar | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DRG Instruments GMBH | MARBURG Hesse, Germany | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dxterity Diagnostics Inc. | Torrance, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dyad Enterprise LLC | King of Prussia, PA, United States | Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Hong De Medical Plastic Products Co. Ltd. | Dongguan Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan SafeSecure Plastics Co., Ltd. | Dongguan City Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Epitope Diagnostics, Inc. | San Diego, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Focus Tendence Corporation | Taichung, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GD Group Co., Ltd. | Eumseong Chungbuk, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gene By Gene | Houston, TX, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Genetrack Biolabs Inc. | Vancouver British Columbia, Canada | Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Geschuetzte Werkstaetten Integrative Betriebe Salzburg GMBH | St. Margareten Salzburg, Austria | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GLX Medical Devices Company Limited | Bien Hoa Dong Nai, Vietnam | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GP Medical Devices A/S | Holstebro Midtjylland, Denmark | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Wondfo Biotech Co., Ltd. | Guangzhou Guangdong, China | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Wondfo Biotech Co., Ltd. | Dongguan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Haimen Shengbang Laboratory Equipment Co., Ltd | Haimen Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Rollmed Co.,ltd. | Hangzhou Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HBH Biotechnology Limited | Yantai Shandong, China | Exporter to the US, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Heng Rong (xiamen) Plastic Products Co., Ltd. | Xiamen Fujian, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hochuen Medical Sdn. Bhd. | SENAI Johor, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Home Access Health Corp. | Hoffman Est, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huachenyang(shenzhen)technology Co., Ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hochuen Medical Technology Co.,Ltd. | Shenzhen Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huakang Packaging Technology Co., Ltd. | Prey Nob Preah Sihanouk, Cambodia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Immundiagnostik AG | Bensheim Hesse, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Imperial Surgical Ltd. | Lachine Quebec, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intelligent Fingerprinting Limited | Cambridge Cambridgeshire, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| J Summit Co., Ltd. | Chomthong Krung Thep Maha Nakhon, Thailand | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Kangjian Medical Apparatus Co., Ltd. | JIANGYAN Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jinan Babio Biotechnology Co.,ltd. | Jinan City Shandong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jinhua Jingdi Medical Supplies Co.,ltd | Jinhua Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Huida Medical Instruments Co., Ltd | Yancheng Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kova International Inc | Garden Grove, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| L-D Tool & Die Division Of Madix Engineering | Ottawa Ontario, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| La Party Corporation Vietnam Co., Ltd | Bau Bang district Binh Duong, Vietnam | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Labcon, North America | Petaluma, CA, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Labone, Inc. | Lenexa, KS, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Les Plastiques MDJ Inc. | Saint-Hubert Quebec, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Liquimedlock | Markham Ontario, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Long Sheng Plastics Tech. Co., Ltd | Douliu Yunlin, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lotus Packaging Trading Service Production Joint Stock Company. | Ho Chi Minh City, Vietnam | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lucid Diagnostics, Inc. | Foxborough, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lords Mark Industries Ltd. | Daman and Diu Dadra and Nagar Haveli, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Med Auxil Analysis Aids E.K. | Seesen Lower Saxony, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Chemical Corporation | Torrance, CA, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medite Medical GMBH | Burgdorf Lower Saxony, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MML Diagnostics Packaging, Inc. | Troutdale, OR, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medegen Medical Products | Gallaway, TN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Minlong Pharmaceutical Biotechnology (Shenzhen) Co., Ltd. | shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Chibanda Imp &exp Co, Ltd | Ningbo Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Ningyuan Import & Export Co., Ltd. | Ningbo, Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Yingmed Medical Instruments Co.,ltd. | Ningbo Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Novogenia GMBH | Eugendorf Salzburg, Austria | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pathright Medical,,inc. | Orem, UT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pathway Medtech, LLC. | Santee, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Peak 5 Packaging LLC | Omaha, NE, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pretium Canada Packaging ULC | ETOBICOKE Ontario, Canada | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Primed Instruments, Inc. | MISSISSAUGA Ontario, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Privapath Diagnostics Ltd | Dublin 11 Dublin(County), Ireland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quicksilver Scientific, Inc. | Louisville, CO, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quanzhou Enrich Hygienic Products Co., Ltd. | Quanzhou Fujian, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Researchdx,inc. | Irvine, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RR Donnelley | Houston, TX, United States | Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Revvity Health Sciences, Inc. | Greenville, SC, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Safesecure Medical Packaging Company Limited | Hai Phong City, Vietnam | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sakura Finetek Europe B.V. | Alphen aan den Rijn Zuid-Holland, Netherlands | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sakura Finetek U.s.a., Inc. | Torrance, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sarstedt AG & Co. KG | NUMBRECHT North Rhine-Westphalia, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sarstedt, Inc. | Newton, NC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Schebo Biotech AG | GIESSEN Hesse, Germany | Foreign private label distributor, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SG BioScience, INC | Dongdaemun-gu Seoul, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shandong Haidike Medical Products Co., Ltd | Heze Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Dochem Industries Co., Ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Huayue Packaging Products Co., Ltd. | Fengxian District, Shanghai, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Leyi Plastic Products Co Ltd | Shanghai, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Youding International Trade Co., Ltd. | Shanghai, China | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shengzyi Enterprise Co., Ltd | Kaohsiung city, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Bairunheng Technology Co., Ltd. | shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Simport Scientific Inc. | BELOEIL Quebec, Canada | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Spot Health Inc. | Cincinnati, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stirilab S.R.O. | Ruzomberok Zilinsky, Slovakia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Labyrinth Biotech Co., Ltd | Suzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Pipi Medical Products Co.,ltd | Suzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SVP Packing Industry Pvt Ltd | MUMBAI Maharashtra, India | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sage Product Development, Inc. | Foxborough, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Chuangshi Medical Technology (Group) Co., Ltd. | Shanghai, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen SafeSecure Medical Infection Control Tech Co., Ltd | Shenzhen City Guangdong, China | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sun Diagnostics, LLC | New Gloucester, ME, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sun Nuclear Corporation | Norfolk, VA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ta Ting Plastic (hai Duong) Co.,ltd | Cam Giang Commune Hai Phong, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Taizhou Rich Medical Products Co., Ltd. | TAIZHOU Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tasso Inc | Seattle, WA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Telimmune, LLC. | North Webster, IN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tissue Protective Products Co., Ltd | tianmen Hubei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Trademark Plastics Inc. | Riverside, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Trajan Scientific Australia Pty Ltd | Ringwood Victoria, Australia | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Therapak, LLC | Oakwood, GA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Therapak, LLC | Claremont, CA, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Typenex Medical, LLC | Chicago, IL, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Unipack Equipment Co., Ltd | Kaohsiung City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| University Medical Devices | Omaha, NE, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Virchow Medical, Inc. | San Diego, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vonco Products, LLC | Trevor, WI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| WESTFIELD MEDICAL LTD (Part of Sterimed) | Radstock Somerset, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Willow Tree Solutions, LLC | East Hartford, CT, United States | Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiamen Chuangkai Industry & Trade Co. Ltd. | Xiamen Fujian, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiamen JPL Industry & Trade Co. Ltd. | Xiang An Area, XiaMen Fujian, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yancheng Jingwei Chemicals Co., Ltd | Yancheng Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yantai Bagmart Packaging Co Ltd | Yantai Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yeni Biyoteknoloji Anonim Sirketi | BALCOVA Izmir, Turkey | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Gene Science Co., Ltd | shaoxing Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Runlab Technology Co., Ltd. | Taizhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Gongdong Medical Technology Co., Ltd | TAIZHOU Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Sorfa Life Science Research Co., Ltd. | Hangzhou Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). 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. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.