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Wrap-around Elbow Support
EUDAMEDClass I (EU MDR)
Ref 316001(Universal/UNI/Black)Model Elbow Strap With Pad:310002 Elbow Strap:310003 Airform Elbow Strap:310004 Neoprene Elbow Sleeve:310005 Airform Elbow Strap:310006 Tennis Elbow Brace:310007 Tennis Elbow Air Brace:310008 etc
Identity
- Trade Name
- Wrap-around Elbow Support EUDAMED
- Device Name
- Elbow Brace, Post-OP Brace (Elbow orthosis) EUDAMED
- Model / Reference
- Elbow Strap With Pad:310002 Elbow Strap:310003 Airform Elbow Strap:310004 Neoprene Elbow Sleeve:310005 Airform Elbow Strap:310006 Tennis Elbow Brace:310007 Tennis Elbow Air Brace:310008 etc EUDAMED316001(Universal/UNI/Black) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719964463849 EUDAMED
- Basic UDI-DI
- 47199644631W9 EUDAMED
- EMDN Code
- Y060615 ELBOW ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Wrap-around Elbow Support by Orthotech Rehabilitation 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 | 47199644631W9 | Class I | Active |
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Manufacturer
- Manufacturer
- Orthotech Rehabilitation Co., Ltd.
- EUDAMED SRN
- CN-MF-000051924
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED ca84d21a-7c5b-42bf-9fbf-858620f41806 61 fields · synced Oct 6, 2026