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Lumbar Support
EUDAMEDClass I (EU MDR)
Ref 2366-GB-M-1Ref 2366-GB-XL-1Ref 2366-GB-S-1Ref 2366-GB-XXL-1
Identity
- Trade Name
- Lumbar Support EUDAMED
- Device Name
- SPINE ORTHOSES EUDAMED
- Model / Reference
- 2366-GB-M-1 EUDAMED2366-GB-XL-1 EUDAMED2366-GB-S-1 EUDAMED2366-GB-XXL-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04716609639683 EUDAMED04716609639706 EUDAMED04716609639676 EUDAMED04716609639713 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
Yes
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
Lumbar 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 12d77bb9-b2bf-420f-b7f0-44473bb647ac 61 fields · synced Oct 6, 2026
- EUDAMED 14c85d00-ea57-4b68-a38f-c7adb7f4e727 61 fields · synced May 16, 2026
- EUDAMED 21a5754b-3ea6-44eb-8e36-8fbacccba428 61 fields · synced May 17, 2026
- EUDAMED 67751e95-bea0-437c-9558-04372da9116a 61 fields · synced May 18, 2026