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COOLPRENE X Back Support with Extra Waist Support and Bilateral Compressive Str…
EUDAMEDClass I (EU MDR)
Ref 573CAR1-BK-S
Identity
- Trade Name
- COOLPRENE X Back Support with Extra Waist Support and Bilateral Compressive Straps EUDAMED
- Device Name
- SPINE ORTHOSES EUDAMED
- Model / Reference
- 573CAR1-BK-S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269504778 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
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
COOLPRENE X Back Support with Extra Waist Support and Bilateral Compressive Str… 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 4bfccb40-0e2a-4ea5-947d-9553330532e2 61 fields · synced Jun 18, 2026