← Back to catalogue
Airform Elbow Strap
EUDAMEDClass I (EU MDR)
Ref 310004(Universal/UNI/Blue)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 310006(Universal/UNI/Black)
Identity
- Trade Name
- Airform Elbow Strap 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 EUDAMED310004(Universal/UNI/Blue) EUDAMED310006(Universal/UNI/Black) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719872862161 EUDAMED04719872869337 EUDAMED
- Basic UDI-DI
- 47198728631WB EUDAMED
- EMDN Code
- Y060615 ELBOW ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Airform Elbow Strap 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 (2)
- EUDAMED 3f425eeb-188e-4bfe-9955-475bb89fd79f 61 fields · synced Oct 6, 2026
- EUDAMED 9b476412-562e-4761-a58b-ace79d85e53e 61 fields · synced May 17, 2026