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Back Support with Extra Lumbar Support and Bilateral Compressive Straps
EUDAMEDClass I (EU MDR)
Ref 919R1-BK-XXL
Identity
- Trade Name
- Back Support with Extra Lumbar Support and Bilateral Compressive Straps EUDAMED
- Device Name
- SPINE ORTHOSES EUDAMED
- Model / Reference
- 919R1-BK-XXL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269505621 EUDAMED
- Basic UDI-DI
- 08402695CL1048J EUDAMED
- EMDN Code
- Y060399 SPINE ORTHOSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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 with Extra Lumbar Support and Bilateral Compressive Straps by La Pointique Int´l Ltd. — Class I — MDR — listed in EUDAMED
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 | 08402695CL1048J | Class I | Active |
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Manufacturer
- Manufacturer
- La Pointique Int´l Ltd.
- EUDAMED SRN
- US-MF-000005204
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED 67a731ad-9fb0-4fab-832a-e9f90ab71671 61 fields · synced Jun 19, 2026