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COOLPRENE X Ankle Brace with Figure 8 Straps
EUDAMEDClass I (EU MDR)
Ref 757CAR1-BK-L/XLRef 757CAR1-BK-S/M
Identity
- Trade Name
- COOLPRENE X Ankle Brace with Figure 8 Straps EUDAMED
- Device Name
- LOWER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- 757CAR1-BK-L/XL EUDAMED757CAR1-BK-S/M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269507564 EUDAMED00840269506994 EUDAMED
- Basic UDI-DI
- 08402695CL1028E EUDAMED
- EMDN Code
- Y061299 LOWER EXTREMITY 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 X Ankle Brace with Figure 8 Straps 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 | 08402695CL1028E | 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 (2)
- EUDAMED ad1da102-1f41-4ae9-82d9-aebda58d42b6 61 fields · synced Oct 5, 2026
- EUDAMED 1b1d326a-d8ea-445e-a55c-cb97d37fbd14 61 fields · synced May 17, 2026