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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 2 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| OKB OTC Hearing Aid - Bluetooth Earphones | HT001 | FDA UDI | Class II | Active |
| HotTip | CL-A1 | FDA UDI | Class I | Active |
| CI Tip | CSA | FDA UDI | Class I | Active |
| Needle | HSN2423 | FDA UDI | Class I | Active |
| Needle | HSN5020 | FDA UDI | Class I | Active |
| CI Tip | CI120-E | FDA UDI | Class I | Active |
| Needle | HSN2820 | FDA UDI | Class I | Active |
| DB Tip | DB-0E | FDA UDI | Class I | Active |
| Needle | HMN2423 | FDA UDI | Class I | Active |
| OKB OTC Hearing Aid | GV-SA03.60 | FDA UDI | Class II | Active |
| B&L-Beta(P) | WL-B1 | FDA UDI | Class I | Active |
| DS Tip | DS-RA | FDA UDI | Class I | Active |
| DS Tip | DS-SE | FDA UDI | Class I | Active |
| PVS Tip | PVSE | FDA UDI | Class I | Active |
| Digital Ruler AL PAD | DGRAP | FDA UDI | Class I | Active |
| DB Tip | DB-0A | FDA UDI | Class I | Active |
| B&L-Beta(P) | WL-B1 | FDA UDI | Class I | Active |
| P Tip | PT-2A | FDA UDI | Class I | Active |
| HotShot | BP-B1 | FDA UDI | Class I | Active |
| Plugger | HT3504 | FDA UDI | Class I | Active |
| CA Tip | CA90-E | FDA UDI | Class I | Active |
| TruePoint | 64233 | FDA UDI | Class II | Active |
| NeoGlide Resin Instruments | NGR#1 | FDA UDI | Class I | Active |
| BL Clamp | CLAMP13A | FDA UDI | Class I | Active |
| B&L-Alpha II(P) | CL-A1 | FDA UDI | Class I | Active |
| TruePoint | 64236 | FDA UDI | Class II | Active |
| Needle | HSN2823 | FDA UDI | Class I | Active |
| Beta Mini(P) | BP-B1 | FDA UDI | Class I | Active |
| BL Clamp | CLAPM12A | FDA UDI | Class I | Active |
| Plugger | HT4504 | FDA UDI | Class I | Active |
| Plugger | HT5510 | FDA UDI | Class I | Active |
| Needle | HSN2225 | FDA UDI | Class I | Active |
| Needle | HSNSET | FDA UDI | Class I | Active |
| Plugger | HT5508 | FDA UDI | Class I | Active |
| CI Tip | CSE | FDA UDI | Class I | Active |
| BL Clamp | CLAMP201 | FDA UDI | Class I | Active |
| B&L-Beta | WL-B1 | FDA UDI | Class I | Active |
| Needle | HMN2425 | FDA UDI | Class I | Active |
| BL Clamp | CLAMP211 | FDA UDI | Class I | Active |
| Digital ruler Silicone PAD | DGRSP | FDA UDI | Class I | Active |
| P Tip | PT-3E | FDA UDI | Class I | Active |
| Needle | HSN2625 | FDA UDI | Class I | Active |
| Needle | HSN2220 | FDA UDI | Class I | Active |
| Needle | HSN2420 | FDA UDI | Class I | Active |
| Perfect 3 Multi Blood Glucose Test Strips | OK1M | FDA UDI | Class II | Active |
| CA Tip | CA120-A | FDA UDI | Class I | Active |
| DB Tip | DB-3A | FDA UDI | Class I | Active |
| Needle | HMN2420 | FDA UDI | Class I | Active |
| CI Tip | CI90-A | FDA UDI | Class I | Active |
| DS Tip | DS-LE | FDA UDI | Class I | Active |
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Authorised Representatives
- MDSS GmbH DE
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