← Back to catalogue
Nu-Form Ankle Brace with Fig-8 Straps, Black, SM
EUDAMEDClass I (EU MDR)
Ref 25003-2BModel Nu-Form Ankle Brace
Identity
- Trade Name
- Nu-Form Ankle Brace with Fig-8 Straps, Black, SM EUDAMED
- Device Name
- Ankle Brace Devices EUDAMED
- Model / Reference
- Nu-Form Ankle Brace EUDAMED25003-2B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810047432258 EUDAMED
- Basic UDI-DI
- 081004743BZR EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Nu-Form Ankle Brace with Fig-8 Straps, Black, SM by Ovation Medical — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081004743BZR | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ovation Medical
- EUDAMED SRN
- US-MF-000051616
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED e22af49a-f02a-4a4b-99a9-dc44aad70b09 61 fields · synced Jun 19, 2026