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Taiwan·TW-MF-000028031
Last updated September 17, 2026
Information
- Country
- Taiwan
- Address
- No. 91, Sec. 2, Gongdao 5th Rd, Hsinchu City, Taiwan
- Website
- www.okbiotech.com/
- —
- —
- [email protected]
- Phone
- +886 3 5160258
- PRRC Contact
- Gary Wei
- EUDAMED SRN
- TW-MF-000028031
- FDA FEI Number
- 3005862821
- DUNS Number
- 658796458
Catalogue (129)
Page 3 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Beta Mini(P) | BP-B1 | FDA UDI | Class I | Active |
| Needle | BSN2220 | FDA UDI | Class I | Active |
| DS Tip | DS-SA | FDA UDI | Class I | Active |
| DS Tip | DS-XLE | FDA UDI | Class I | Active |
| Endodontic Explorer | ENEX | FDA UDI | Class I | Active |
| TruePoint | 64200 | FDA UDI | Class I | Active |
| Plugger | HT5004 | FDA UDI | Class I | Active |
| CA Tip | CA120-E | FDA UDI | Class I | Active |
| DS Tip | DS-XRE | FDA UDI | Class I | Active |
| Plugger | HT3004 | FDA UDI | Class I | Active |
| Needle | HSN2123 | FDA UDI | Class I | Active |
| OKmeter Match Premium Blood Glucose Monitoring System | OK-1GJ | EUDAMED | IVD Annex II List B | Active |
| PRODIGY iConnect Blood Glucose Monitoring System | K142785 | FDA 510(k) | Class II | Active |
| Okmeter Direct Blood Glucose Monitoring System | K132633 | FDA 510(k) | Class II | Active |
| UniStrip1 Generic Blood Glucose Test Strips | K160038 | FDA 510(k) | Class II | Active |
| B&L L-Beta, Model Wl-B1 | K060347 | FDA 510(k) | Class I | Active |
| Okmeter Match Blood Glucose Monitoring System | K090609 | FDA 510(k) | Class II | Active |
| UniStrip1 Generic Blood Glucose Test Strips | K162430 | FDA 510(k) | Class II | Active |
| Ok Meter Blood Glucose Monitoring System | K063026 | FDA 510(k) | Class II | Active |
| PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring System | K152599 | FDA 510(k) | Class II | Active |
| Prodigy Autocode Eject Blood Glucose Monitoring System | K141914 | FDA 510(k) | Class II | Active |
| SuperCheck Pro Blood Glucose Monitoring System | K213061 | FDA 510(k) | Class II | Active |
| Avital Blood Glucose Test Strip | OK2M | EUDAMED | IVD Annex II List B | Active |
| Solus V2 Blood Glucose Monitoring System | 6131 | EUDAMED | IVD Annex II List B | Active |
| Solus V2 Glucose Control Solution | GCS | EUDAMED | IVD Annex II List B | Active |
| Avital Blood Glucose Monitoring System | 6276 | EUDAMEDFDA UDI | IVD Annex II List B | Active |
| OKmeter Match Premium Blood Glucose Strip | OK1 | EUDAMED | IVD Annex II List B | Active |
| VOX Blood Glucose Test Strips | OK3I | EUDAMED | IVD Annex II List B | Active |
| Solus V2 Glucose Test Strips | OK2M | EUDAMED | IVD Annex II List B | Active |
Related Companies
Authorised Representatives
- MDSS GmbH DE
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