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Orthese Cheville Premium Gamme Orthomarine
EUDAMEDClass I (EU MDR)
Ref 813.005
by Medisport
Identity
- Trade Name
- ORTHESE CHEVILLE PREMIUM GAMME ORTHOMARINE EUDAMED
- Device Name
- Attelle de Cheville Mousse EUDAMED
- Model / Reference
- 813.005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03664617007813 EUDAMED
- Basic UDI-DI
- 3664617CHV01TX EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Category: Ankle/foot orthosis
Orthese Cheville Premium Gamme Orthomarine by Medisport — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 3664617CHV01TX | Class I | Active |
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Manufacturer
- Manufacturer
- Medisport
- EUDAMED SRN
- FR-MF-000000677
Sources (1)
- EUDAMED 7c143752-9edd-4a3b-891c-607f1dd04a75 61 fields · synced Oct 6, 2026