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Lumbar Protector
EUDAMEDClass I (EU MDR)
Ref 2350-GY-XL-1Ref 2350-GY-M-1Ref 2350-GY-S-1Ref 2350-GY-XXL-1
Identity
- Trade Name
- Lumbar Protector EUDAMED
- Device Name
- SPINE ORTHOSES EUDAMED
- Model / Reference
- 2350-GY-XL-1 EUDAMED2350-GY-M-1 EUDAMED2350-GY-S-1 EUDAMED2350-GY-XXL-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04716609639102 EUDAMED04716609639089 EUDAMED04716609639072 EUDAMED04716609639119 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 Protector 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 81cc3ec1-1fc9-4eaa-b675-586476d42d22 61 fields · synced Oct 6, 2026
- EUDAMED 1dc07996-103c-492f-9edb-def0fcd0ea27 61 fields · synced May 18, 2026
- EUDAMED c047f4ff-4ebe-4528-8358-2c39e523ee95 61 fields · synced May 19, 2026
- EUDAMED e564c0ef-186d-42b7-8d39-b6c53a23c5af 61 fields · synced May 19, 2026