Identity
- Trade Name
- Neen EUDAMED
- Device Name
- Anuform EUDAMED
- Model / Reference
- 091253632 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-AnuformB9 EUDAMED
- Basic UDI-DI
- B-AnuformB9 EUDAMED
- EMDN Code
- U070399 PELVIC FLOOR REHABILITATION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
Neen by Performance Health International Ltd — Class IIa — 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-AnuformB9 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Performance Health International LTD
- EUDAMED SRN
- GB-MF-000003319
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (1)
- EUDAMED 87e4faea-d9db-431e-8963-bf19207e5f2b 61 fields · synced Jun 19, 2026