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Elbow Strap
EUDAMEDClass I (EU MDR)
Ref 318002(XL/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
- Elbow Strap 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 EUDAMED318002(XL/UNI/Black) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719892937108 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
Elbow Strap 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 bb62307a-b13d-4a61-8b0b-19d2ef6481d8 61 fields · synced Jun 18, 2026