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Versa-Fit Wrist Brace, Right, Standard Size
EUDAMEDClass I (EU MDR)
Ref 59075-2Model Versa-Fit Wrist Brace
Identity
- Trade Name
- Versa-Fit Wrist Brace, Right, Standard Size EUDAMED
- Device Name
- Wrist Brace Devices EUDAMED
- Model / Reference
- Versa-Fit Wrist Brace EUDAMED59075-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810047432685 EUDAMED
- Basic UDI-DI
- 081004743VFWB63 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
Versa-Fit Wrist Brace, Right, 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 | 081004743VFWB63 | 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 94197e5d-fcbc-4745-b9cf-c4c19a778f93 61 fields · synced Jun 19, 2026