Identity
- Trade Name
- Splint EUDAMED
- Device Name
- Splint EUDAMED
- Model / Reference
- ENSXX2AA003 EUDAMEDENSXX2AA001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974686052216 EUDAMED06974686050793 EUDAMED
- Basic UDI-DI
- 697468605SXX2AA02087 EUDAMED
- EMDN Code
- M03050299 BANDAGES AND SPLINTS - OTHER 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
Category: Hand/finger splint, reusable
Splint by Yiwu Ori-Power Medtech 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 | 697468605SXX2AA02087 | Class I | Active |
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Manufacturer
- Manufacturer
- Yiwu Ori-Power Medtech Co., Ltd.
- EUDAMED SRN
- CN-MF-000021146
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (2)
- EUDAMED 506a935d-5b68-4a45-a6b9-a75a57252b27 61 fields · synced Aug 1, 2026
- EUDAMED 6f1dc597-3e04-48a4-b6ff-692f421e02c0 61 fields · synced May 18, 2026