Identity
- Trade Name
- Night Splint EUDAMED
- Device Name
- Bracing & Support EUDAMED
- Model / Reference
- AE007 EUDAMEDNight Splint EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04715109841060 EUDAMED
- Basic UDI-DI
- 47510984AE007BL 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
Night Splint by I Caremed Co., Ltd. — 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 | 47510984AE007BL | 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 8036695e-9538-414d-b109-3becaacc7292 61 fields · synced Jun 18, 2026