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Gel Afta Repair
EUDAMEDClass I (EU MDR)
Ref 8029408126022Ref 8029408130630
by UNIFARCO SpA
Identity
- Trade Name
- Gel Afta Repair EUDAMED
- Device Name
- Gel Afta Repair IT EUDAMEDGEL AFTA REPAIR ES EUDAMED
- Model / Reference
- 8029408126022 EUDAMED8029408130630 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-FPGAFT10IF6 EUDAMEDD-FPGAFT10SFS EUDAMED
- Basic UDI-DI
- B-FPGAFT10IF6 EUDAMEDB-FPGAFT10SFS EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMEDSpain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Device sterilization/disinfection container, reusable
Gel Afta Repair by UNIFARCO SpA — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-FPGAFT10IF6 | Class I | Active |
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Manufacturer
- Manufacturer
- UNIFARCO SpA
- EUDAMED SRN
- IT-MF-000013304
Sources (2)
- EUDAMED fd2ba02a-5e99-4ed4-a2e2-6d49604b45f4 61 fields · synced Jul 17, 2026
- EUDAMED 64c11143-3c26-4d08-92c2-58d4db4d2779 61 fields · synced May 18, 2026