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GentilFoam Border Soft Silicone foam with an adhesive border 100 mm x 100 mm
EUDAMEDClass IIb (EU MDR)
Ref 430404
Identity
- Trade Name
- GentilFoam Border Soft Silicone foam with an adhesive border 100 mm x 100 mm EUDAMED
- Device Name
- Gentilfoam Border 10 x 10 cm EUDAMED
- Model / Reference
- 430404 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00849405000778 EUDAMED
- Basic UDI-DI
- B-00849405000778 EUDAMED
- EMDN Code
- M04040701 SILICONE DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
Yes
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
GentilFoam Border Soft Silicone foam with an adhesive border 100 mm x 100 mm by Genadyne Biotechnologies Inc. — Class IIb — MDD — listed in EUDAMED
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-00849405000778 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Genadyne Biotechnologies, Inc.
- EUDAMED SRN
- US-MF-000017992
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 0baf7f46-7d86-4a75-91d2-db55d108e1fc 61 fields · synced Jul 28, 2026