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Adjustable Back Support
EUDAMEDClass I (EU MDR)
Ref 2352-GY-XL-1Ref 2352-GY-S-1Ref 2352-GY-L-1Ref 2352-GY-M-1
Identity
- Trade Name
- Adjustable Back Support EUDAMED
- Device Name
- SPINE ORTHOSES EUDAMED
- Model / Reference
- 2352-GY-XL-1 EUDAMED2352-GY-S-1 EUDAMED2352-GY-L-1 EUDAMED2352-GY-M-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04716609639256 EUDAMED04716609639485 EUDAMED04716609639508 EUDAMED04716609639492 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
Adjustable 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 62456486-a809-4f96-934b-2c98b35469dc 61 fields · synced Oct 6, 2026
- EUDAMED 2b64d9a7-cf39-4721-a1d7-4a64a83aa24a 61 fields · synced May 17, 2026
- EUDAMED 03fc61a9-1aca-4840-b86f-5921e281a855 61 fields · synced May 18, 2026
- EUDAMED 48e5df26-cfc9-440d-9890-b64c264c002e 61 fields · synced May 18, 2026