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GentilFoam Border Soft Silicone foam with an adhesive border 150 mm x 200 mm
EUDAMEDClass IIb (EU MDR)
Ref 430608
Identity
- Trade Name
- GentilFoam Border Soft Silicone foam with an adhesive border 150 mm x 200 mm EUDAMED
- Device Name
- Gentilfoam Border 15 x 20 cm EUDAMED
- Model / Reference
- 430608 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00849405000815 EUDAMED
- Basic UDI-DI
- B-00849405000815 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 150 mm x 200 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-00849405000815 | 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 fb968ccf-5707-4982-b511-d7dadceb8e37 61 fields · synced Jul 21, 2026