← Back to catalogue
Elbow Strap With Pad
EUDAMEDClass I (EU MDR)
Ref 310002(L/UNI/Gray&Silver)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 310002(M/UNI/Gray&Silver)Ref 310003(M/UNI/Gray&Silver)Ref 310003(L/UNI/Gray&Silver)Ref 310002(S/UNI/Gray&Silver)Ref 310002(XL/UNI/Gray&Silver)Ref 310002(L/UNI/Black)Ref 318002(M/UNI/Black)
Identity
- Trade Name
- Elbow Strap With Pad EUDAMEDElbow 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 EUDAMED310002(L/UNI/Gray&Silver) EUDAMED310002(M/UNI/Gray&Silver) EUDAMED310003(M/UNI/Gray&Silver) EUDAMED310003(L/UNI/Gray&Silver) EUDAMED310002(S/UNI/Gray&Silver) EUDAMED310002(XL/UNI/Gray&Silver) EUDAMED310002(L/UNI/Black) EUDAMED318002(M/UNI/Black) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719872862086 EUDAMED04719872862093 EUDAMED04719872862130 EUDAMED04719872862123 EUDAMED04719872862109 EUDAMED04719872862116 EUDAMED04719892933865 EUDAMED04719872862321 EUDAMED
- Basic UDI-DI
- 47198728631WB EUDAMED
- EMDN Code
- Y060615 ELBOW ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Greece EUDAMEDNetherlands 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 With Pad 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 (8)
- EUDAMED f98b4555-4242-40c4-80a1-4e8cabe48809 61 fields · synced Oct 6, 2026
- EUDAMED 5ca64f56-9855-46a6-b768-c4bf230d660b 61 fields · synced May 17, 2026
- EUDAMED 946fba9b-609f-4bdc-b9ca-64dc1924101f 61 fields · synced May 17, 2026
- EUDAMED 00641e8c-6271-41e1-9ad2-46bc9e10ae3a 61 fields · synced May 18, 2026
- EUDAMED 5d0dbd81-dd99-44a5-9e5d-f8d19a5e9433 61 fields · synced May 18, 2026
- EUDAMED 20f10fbe-b09a-4130-9e0d-a8a833a77e84 61 fields · synced May 19, 2026
- EUDAMED 2bd9e454-e628-4f32-be62-20a6c4e4499e 61 fields · synced May 19, 2026
- EUDAMED fada8f98-3229-4e97-8902-63486d2f643f 61 fields · synced May 19, 2026