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Nu-Form Versa-Fit Thumb Spica Left, Standard Size
EUDAMEDClass I (EU MDR)
Ref 50075-5Model Thumb Spica
Identity
- Trade Name
- Nu-Form Versa-Fit Thumb Spica Left, Standard Size EUDAMED
- Device Name
- Thumb Spica Devices EUDAMED
- Model / Reference
- Thumb Spica EUDAMED50075-5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810047432470 EUDAMED
- Basic UDI-DI
- 081004743E22 EUDAMED
- EMDN Code
- Y060612 WRIST-HAND 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 Versa-Fit Thumb Spica Left, Standard Size 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 | 081004743E22 | Class I | Active |
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Manufacturer
- Manufacturer
- Ovation Medical
- EUDAMED SRN
- US-MF-000051616
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 56ec4646-cdb6-45ee-ab13-3826ea9a0139 61 fields · synced Jun 20, 2026