Identity
- Trade Name
- Ankle Brace with Strap EUDAMED
- Device Name
- Bracing & Support EUDAMED
- Model / Reference
- AE012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04715109841114 EUDAMED
- Basic UDI-DI
- 47510984AE012BD 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
Ankle Brace with Strap by I Caremed Co., Ltd. — 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 | 47510984AE012BD | Class I | Active |
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Manufacturer
- Manufacturer
- I Caremed Co., Ltd.
- EUDAMED SRN
- TW-MF-000028317
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (1)
- EUDAMED 3825709a-e503-479a-b07a-fda9d0022853 61 fields · synced Jul 12, 2026