← Back to catalogue
Elbow Support
EUDAMEDClass I (EU MDR)
Ref 318001(Universal/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 etc
Identity
- Trade Name
- Elbow Support 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 EUDAMED318001(Universal/UNI/Black) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719872862307 EUDAMED
- Basic UDI-DI
- 47198728631WB 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 Support 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zhangpu Ortholife Rehabilitation Co., Ltd.
- EUDAMED SRN
- CN-MF-000011447
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED bb1adbf6-86e4-4e01-adf3-d4b6d61564a0 61 fields · synced Jun 18, 2026