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Lumbar Sacro Support
EUDAMEDClass I (EU MDR)
Ref 2064-BG-L-1Ref 2064-BG-M-1Ref 2064-BG-XXL-1Ref 2064-BG-XS-1Ref 2064-BG-XXXL-1Ref 2064-BG-S-1
Identity
- Trade Name
- Lumbar Sacro Support EUDAMED
- Device Name
- SPINE ORTHOSES EUDAMED
- Model / Reference
- 2064-BG-L-1 EUDAMED2064-BG-M-1 EUDAMED2064-BG-XXL-1 EUDAMED2064-BG-XS-1 EUDAMED2064-BG-XXXL-1 EUDAMED2064-BG-S-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719863691589 EUDAMED04719863691572 EUDAMED04719863691602 EUDAMED04719863693859 EUDAMED04711769148136 EUDAMED04719863691565 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 Sacro 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 (6)
- EUDAMED 9689e113-70f5-47bd-96a0-3b10bb77c471 61 fields · synced Oct 6, 2026
- EUDAMED 5c15aa2d-a9e0-45ce-b0fe-3dc6020e3d89 61 fields · synced May 17, 2026
- EUDAMED 5a518f30-25fd-4791-9f2d-7781be55acd5 61 fields · synced May 17, 2026
- EUDAMED 24b2d9b4-5f4f-489f-b60b-7173d76339c7 61 fields · synced May 18, 2026
- EUDAMED 6e408027-d4ff-426e-a0ff-23257c983148 61 fields · synced May 18, 2026
- EUDAMED 611e5565-b540-41ef-8e04-06d666c68ae9 61 fields · synced May 18, 2026