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- Country
- United States
- Address
- 5975, Shiloh Road, Alpharetta, United States
- Website
- www.biotechinc.com
- —
- —
- [email protected]
- Phone
- +1 678 341 8136
- PRRC Contact
- Carina Castillo
- EUDAMED SRN
- US-MF-000002378
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (11)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Fx-Cablelok System | K922142 | FDA 510(k) | Class II | Active |
| Smart-Read Eztest-Steam Scbi And Test Pack | K093794 | FDA 510(k) | Class II | Active |
| Eztest-Steam | K930682 | FDA 510(k) | Class II | Active |
| Korlex-Gr Gingival Retraction Paste | K053329 | FDA 510(k) | U | Active |
| EGIS Biliary Single Bare Stent | K223354 | FDA 510(k) | Class II | Active |
| Consti-Ssage Vibrator/Massage | K900674 | FDA 510(k) | Class I | Active |
| Smart-Well Eztest Incubator | K091950 | FDA 510(k) | Class II | Active |
| Bonamates Series | K040650 | FDA 510(k) | Class II | Active |
| Eztest | K963841 | FDA 510(k) | Class II | Active |
| Cryolock | CL-R-CT | EUDAMED | Class IIa | Active |
| S-Cryolock | S-CL | EUDAMED | Class IIa | Active |
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