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WellKnit Elbow Brace
EUDAMEDClass I (EU MDR)
Ref 314001(S/UNI/Black)Model Airform Elbow Strap:310004 Airform Elbow Strap:310006 Athena Elbow Support:312003 Elastic Elbow Support:312001 Elastic Elbow Support:312002 Elbow Strap:310003 Elbow Strap:318002 Elbow Strap With Pad:310002 etcRef 314001(XL/UNI/Black)Ref 314001(L/UNI/Black)Ref 314001(M/UNI/Black)
Identity
- Trade Name
- WellKnit Elbow Brace EUDAMED
- Device Name
- Elbow Brace, Post-OP Brace (Elbow orthosis) EUDAMED
- Model / Reference
- Airform Elbow Strap:310004 Airform Elbow Strap:310006 Athena Elbow Support:312003 Elastic Elbow Support:312001 Elastic Elbow Support:312002 Elbow Strap:310003 Elbow Strap:318002 Elbow Strap With Pad:310002 etc EUDAMED314001(S/UNI/Black) EUDAMED314001(XL/UNI/Black) EUDAMED314001(L/UNI/Black) EUDAMED314001(M/UNI/Black) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719892932523 EUDAMED04719892932509 EUDAMED04719872862352 EUDAMED04719892932516 EUDAMED
- Basic UDI-DI
- 47198728631WB EUDAMED
- EMDN Code
- Y060615 ELBOW ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
WellKnit Elbow Brace by Zhangpu Ortholife 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 | 47198728631WB | Class I | Active |
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Manufacturer
- Manufacturer
- Zhangpu Ortholife Rehabilitation Co., Ltd.
- EUDAMED SRN
- CN-MF-000011447
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (4)
- EUDAMED d91ebc7e-3913-4430-9220-57a0e22b755b 61 fields · synced Oct 6, 2026
- EUDAMED 3af8c86d-85ac-447b-9fab-3a7e21aa9c5e 61 fields · synced May 18, 2026
- EUDAMED ec9fa6ad-6f9c-4719-bd14-85046073d1d9 61 fields · synced May 18, 2026
- EUDAMED 18f4670d-8efa-4485-8153-6e7c6286c696 61 fields · synced May 18, 2026