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Back Support
EUDAMEDClass I (EU MDR)
Ref 2950-GY-L-1Ref 2950-GY-M-1Ref 2950-GY-S-1Ref 2950-GY-XL-1
Identity
- Trade Name
- Back Support EUDAMED
- Device Name
- SPINE ORTHOSES EUDAMED
- Model / Reference
- 2950-GY-L-1 EUDAMED2950-GY-M-1 EUDAMED2950-GY-S-1 EUDAMED2950-GY-XL-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04711769154021 EUDAMED04711769154014 EUDAMED04711769154007 EUDAMED04711769154038 EUDAMED
- Basic UDI-DI
- 471986369CL104DK EUDAMED
- EMDN Code
- Y060399 SPINE ORTHOSES - OTHER 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
Back Support by OPPO Medical Corp. — 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 | 471986369CL104DK | Class I | Active |
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Manufacturer
- Manufacturer
- OPPO Medical Corp.
- EUDAMED SRN
- TW-MF-000005201
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (4)
- EUDAMED 6839bfa1-a30d-4eab-9b9f-8859df1de781 61 fields · synced Aug 4, 2026
- EUDAMED 03335bd6-44b6-49a8-818b-0ef854328da0 61 fields · synced May 11, 2026
- EUDAMED f196e768-8c50-4b49-9917-3e3eb04a6287 61 fields · synced May 17, 2026
- EUDAMED 3e4151dc-dc47-4559-86f0-e7f337101bc6 61 fields · synced May 17, 2026