Is this your brand? Sign in to claim ownership.
Sign in to claim this brandTepha, Inc.
US
Last updated May 27, 2026
Information
- Country
- US
- Address
- —
- Website
- galateasurgical.com
- —
- —
- [email protected]
- Phone
- 781-357-1750
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 039856765
Catalogue (99)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| GalaSHAPE 3D | 100042-08 | FDA UDI | Class II | Unknown |
| GalaFLEX 3D | 100042-06 | FDA UDI | Class II | Active |
| GalaFLEX Scaffold | 100035-01 | FDA UDI | Class II | Active |
| GalaFLEX Scaffold | 100035-23 | FDA UDI | Class II | Unknown |
| GalaFLEX 3DR | 100043-14 | FDA UDI | Class II | Unknown |
| GalaFLEX LITE | 100027-33 | FDA UDI | Class II | Active |
| GalaFLEX LITE | 100027-30 | FDA UDI | Class II | Active |
| GalaFLEX 3D | 100042-11 | FDA UDI | Class II | Unknown |
| GalaFORM 3D | 100043-01 | FDA UDI | Class II | Unknown |
| GalaFLEX 3D | 100042-08 | FDA UDI | Class II | Unknown |
| GalaFLEX LITE | 100027-05 | FDA UDI | Class II | Active |
| GalaFLEX 3DR | 100043-02 | FDA UDI | Class II | Active |
| GalaSHAPE 3D | 100042-04 | FDA UDI | Class II | Unknown |
| GalaFLEX LITE | 100027-32 | FDA UDI | Class II | Active |
| GalaFLEX LITE | 100027-15 | FDA UDI | Class II | Active |
| GalaFLEX Scaffold | 100035-26 | FDA UDI | Class II | Unknown |
| GalaFLEX 3DR | 100043-05 | FDA UDI | Class II | Active |
| GalaFLEX 3DR | 100043-12 | FDA UDI | Class II | Unknown |
| GalaFORM 3D | 100043-04 | FDA UDI | Class II | Unknown |
| GalaFLEX LITE | 100027-14 | FDA UDI | Class II | Active |
| GalaFLEX Scaffold | 100035-28 | FDA UDI | Class II | Unknown |
| GalaSHAPE 3D | 100042-07 | FDA UDI | Class II | Unknown |
| GalaFLEX Scaffold | 100035-19 | FDA UDI | Class II | Unknown |
| GalaFLEX Scaffold | 100035-20 | FDA UDI | Class II | Unknown |
| GalaFLEX Scaffold | 100035-14 | FDA UDI | Class II | Active |
| GalaFLEX LITE | 100027-03 | FDA UDI | Class II | Active |
| GalaFLEX 3D | 100042-09 | FDA UDI | Class II | Unknown |
| GalaFLEX 3DR | 100043-06 | FDA UDI | Class II | Active |
| GalaFLEX 3D | 100042-03 | FDA UDI | Class II | Active |
| GalaFLEX 3DR | 100043-09 | FDA UDI | Class II | Unknown |
| GalaFLEX 3D | 100042-12 | FDA UDI | Class II | Unknown |
| SurgiLattice scaffold | K202425 | FDA 510(k) | Class II | Active |
| Tephaflex Absorbable Suture | K081099 | FDA 510(k) | Class II | Active |
| Tephaflex Absorbable Suture | K082178 | FDA 510(k) | Class II | Active |
| Tephaflex Mesh | K113723 | FDA 510(k) | Class II | Active |
| Tephaflex Surgical Film | K072520 | FDA 510(k) | Class II | Active |
| GalaSHAPE 3D | K161092 | FDA 510(k) | Class II | Active |
| GalaFLEX LITE Scaffold | K233999 | FDA 510(k) | Class II | Active |
| GalaSTITCH Absorbable Monofilament Suture | K211307 | FDA 510(k) | Class II | Active |
| Tephaflex Braided Suture | K132348 | FDA 510(k) | Class II | Active |
| GalaFORM 3D | K162922 | FDA 510(k)FDA UDI | Class II | Active |
| Tephaflex Surgical Mesh | K070894 | FDA 510(k) | Class II | Active |
| Galaflex Mesh | K140533 | FDA 510(k) | Class II | Active |
| Tephaflex Mesh | K111946 | FDA 510(k) | Class II | Active |
| Tephaflex Composite Mesh | K101287 | FDA 510(k) | Class II | Active |
| Tephaflex Surgical Film | K091633 | FDA 510(k) | Class II | Active |
| Tephaflex Light Mesh | K113721 | FDA 510(k) | Class II | Active |
| Tephaflex Absorbable Suture | DEN060003 | FDA 510(k) | Class II | Active |
| Tephaflex Meltblown Construct | K130326 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.