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Nanogen Aktiv NANO-STRUCTURED MEMBRANE 8cm x 8cm [EN]
EUDAMEDClass IIb (EU MDR)
Ref 610303
Identity
- Trade Name
- Nanogen Aktiv NANO-STRUCTURED MEMBRANE 8cm x 8cm [EN] EUDAMED
- Device Name
- Nanogen Aktiv 8cm x 8cm EUDAMED
- Model / Reference
- 610303 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00849405000150 EUDAMED
- Basic UDI-DI
- B-00849405000150 EUDAMED
- EMDN Code
- M040404 CELLULOSE AND/OR MODIFIED CELLULOSE DRESSINGS, NON-COMBINED OR COMBINED WITH OTHER SUBSTANCES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy 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
Nanogen Aktiv NANO-STRUCTURED MEMBRANE 8cm x 8cm [EN] by Genadyne Biotechnologies Inc. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-00849405000150 | 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 56662cc1-d5a7-4de7-814c-b9471af837bc 61 fields · synced Jul 18, 2026