Data / Medical devices / Taiwan / Monitex Industrial Co., Ltd.
Monitex Industrial Co., Ltd.: FDA-registered device maker in SAN-CHUNG CITY Taipei, Taiwan, 1 510(k) clearance
Monitex Industrial Co., Ltd. is registered with the FDA (registration 3003169405) in SAN-CHUNG CITY Taipei, Taiwan. It lists 8 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 7, 2017. Registered through 2026. 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.
- FDA registration number
- 3003169405
- Address
- 6F, 70 Guang-Fu RD., Sec 1, SAN-CHUNG CITY Taipei, Taiwan, 241-58
- Owner or operator
- MONITEX INDUSTRIAL CO., LTD. (9044777)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- November 21, 2007
- Registered through
- 2026
- Brand names listed
- ACE, Darby, HPR Cordless Hygiene Handpiece, Henry Schein, Kerr, Maxima Advanced 3000 LED Curing Light, Monitex Industrial Co., Ltd GX-330, SHOFU DENTAL CORPORATION and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Activator, Ultraviolet, For Polymerization | EBZ | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Amalgamator, Dental, Ac-Powered | EFD | 1 | Contract manufacturer | accessdata.fda.gov |
| Handpiece, Direct Drive, Ac-Powered | EKX | 1 | Contract manufacturer | accessdata.fda.gov |
| Heat Source For Bleaching Teeth | EEG | 1 | Contract manufacturer | accessdata.fda.gov |
| Material, Impression Tray, Resin | EBH | 1 | Contract manufacturer | accessdata.fda.gov |
| Mixer, Cement, For Clinical Use | JDZ | 1 | Contract manufacturer | accessdata.fda.gov |
| Syringe, Irrigating (Non Dental) | KYZ | 1 | Manufacturer | accessdata.fda.gov |
| Syringe, Restorative And Impression Material | EID | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 7, 2017 | K152192 | LED Curing Light | EBZ | Substantially Equivalent | Monitex Industrial Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Material, Impression Tray, Resin
- All makers of Activator, Ultraviolet, For Polymerization
- All makers of Heat Source For Bleaching Teeth
- All makers of Mixer, Cement, For Clinical Use
- All makers of Amalgamator, Dental, Ac-Powered
- All makers of Syringe, Irrigating (Non Dental)
Updated April 7, 2017. 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.