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Post-op Elbow Brace
EUDAMEDClass I (EU MDR)
Ref 311001(Universal/Right/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 etcRef 311001(Universal/Left/Black)Ref 311002(Universal/Right/Gray&Silver)Ref 311002(Universal/Left/Gray&Silver)
Identity
- Trade Name
- Post-op Elbow Brace EUDAMEDG2 Post-op Elbow Brace 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 EUDAMED311001(Universal/Right/Black) EUDAMED311001(Universal/Left/Black) EUDAMED311002(Universal/Right/Gray&Silver) EUDAMED311002(Universal/Left/Gray&Silver) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719892936781 EUDAMED04719892936774 EUDAMED04719964463788 EUDAMED04719964463771 EUDAMED
- Basic UDI-DI
- 47199644631W9 EUDAMED
- EMDN Code
- Y060615 ELBOW ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Greece EUDAMEDIreland 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
Post-op Elbow Brace 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 (4)
- EUDAMED 586c94fa-4a2c-41df-9eff-8b88f58161f9 61 fields · synced Oct 6, 2026
- EUDAMED 6c757ae4-100b-4555-9288-95d3f6cbb5a6 61 fields · synced May 16, 2026
- EUDAMED 9f06eeb7-4e55-4058-94d3-5e19e1a990a1 61 fields · synced May 19, 2026
- EUDAMED a2470e5e-f750-4f1c-a05c-e5bd5b33342d 61 fields · synced May 19, 2026