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COOLPRENE Ankle Support with Rear Adjustable Strap
EUDAMEDClass I (EU MDR)
Ref 768CN-TAN-SRef 768CN-TAN-LRef 768CN-BL-LRef 768CN-BL-MRef 768CN-BK-LRef 768CN-TAN-XLRef 768CN-TAN-MRef HMA100-BK-F
Identity
- Trade Name
- COOLPRENE Ankle Support with Rear Adjustable Strap EUDAMEDCOOLPRENE ANKLE SUPPORT EUDAMED
- Device Name
- LOWER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- 768CN-TAN-S EUDAMED768CN-TAN-L EUDAMED768CN-BL-L EUDAMED768CN-BL-M EUDAMED768CN-BK-L EUDAMED768CN-TAN-XL EUDAMED768CN-TAN-M EUDAMEDHMA100-BK-F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269504839 EUDAMED00840269505584 EUDAMED00840269504815 EUDAMED00840269504655 EUDAMED00840269507366 EUDAMED00840269505591 EUDAMED00840269504846 EUDAMED00840269528323 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 Ankle Support with Rear Adjustable Strap 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 (8)
- EUDAMED c0867b63-095f-4522-817c-c3a57f5e64ab 61 fields · synced Jul 31, 2026
- EUDAMED 384f89f3-a604-42ed-8387-fd03ef70ddf8 61 fields · synced May 16, 2026
- EUDAMED cdd3630f-e83b-49e9-881a-a933b11ba105 61 fields · synced May 16, 2026
- EUDAMED 18ae65db-a5bb-428d-b67c-3d08fbe863a6 61 fields · synced May 17, 2026
- EUDAMED 40b73719-c78f-40f5-b845-705a98489fc5 61 fields · synced May 17, 2026
- EUDAMED 9262cfd4-46d1-4e73-bbcc-e63da6ede791 61 fields · synced May 18, 2026
- EUDAMED af2ca2a2-3d1e-4475-93ef-1e9a88dc7395 61 fields · synced May 18, 2026
- EUDAMED e3adda3e-b023-4e12-9fbf-01ac9b3e25e8 61 fields · synced May 18, 2026