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Coolprene Back Support With Extra Lumbar Support
EUDAMEDClass I (EU MDR)
Ref 772CN-BL-XLRef 772CN-TAN-LRef 772CN-BK-MRef 772CN-BL-MRef 772CN-TAN-S
Identity
- Trade Name
- COOLPRENE BACK SUPPORT WITH EXTRA LUMBAR SUPPORT EUDAMED
- Device Name
- SPINE ORTHOSES EUDAMED
- Model / Reference
- 772CN-BL-XL EUDAMED772CN-TAN-L EUDAMED772CN-BK-M EUDAMED772CN-BL-M EUDAMED772CN-TAN-S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269527609 EUDAMED00840269527630 EUDAMED00840269527548 EUDAMED00840269527586 EUDAMED00840269527616 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
Coolprene Back Support With Extra Lumbar Support by La Pointique Int´l Ltd. — 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 | 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 (5)
- EUDAMED 7ee365c8-1366-4592-9858-4356de0a8842 61 fields · synced Jul 22, 2026
- EUDAMED 02aa4e55-8e77-4df1-a90a-b46adfad0800 61 fields · synced May 18, 2026
- EUDAMED 88f6618a-1913-428d-aca3-6d36cde9c2a9 61 fields · synced May 18, 2026
- EUDAMED 8b199f84-64ef-41ee-954d-01758f1e2597 61 fields · synced May 18, 2026
- EUDAMED 14d6e9ed-66cb-4b98-a8a8-11ee4e3e3b26 61 fields · synced May 19, 2026