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COOLPRENE Patella Strap
EUDAMEDClass I (EU MDR)
Ref 781CN-BL-FRef 781CN-GY-FRef 781CN-AZ-FRef HMK100-BK-FRef 769CN-TAN-FRef 781CN-RD-FRef 781CN-BK-FRef 769CN-BL-F
Identity
- Trade Name
- COOLPRENE Patella Strap EUDAMED
- Device Name
- LOWER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- 781CN-BL-F EUDAMED781CN-GY-F EUDAMED781CN-AZ-F EUDAMEDHMK100-BK-F EUDAMED769CN-TAN-F EUDAMED781CN-RD-F EUDAMED781CN-BK-F EUDAMED769CN-BL-F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269507601 EUDAMED00840269507618 EUDAMED00840269507595 EUDAMED00840269528507 EUDAMED00840269527128 EUDAMED00840269507625 EUDAMED00840269506925 EUDAMED00840269527111 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 Patella 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 eda979fa-5c6e-4b0a-b71d-d12367b49764 61 fields · synced Sep 30, 2026
- EUDAMED 189d70bb-0db2-42fc-a269-65e4dff21e54 61 fields · synced May 11, 2026
- EUDAMED b9227e66-a7bd-4b2b-9503-74c3e454f3a8 61 fields · synced May 16, 2026
- EUDAMED 77f85c68-2d68-4196-b3b0-4de0b7cbf38c 61 fields · synced May 17, 2026
- EUDAMED 1fda28f7-6323-4c31-b968-56c1962eef20 61 fields · synced May 18, 2026
- EUDAMED 7aedca2a-03c7-48de-acce-1b8308647d11 61 fields · synced May 18, 2026
- EUDAMED 796ceabd-4ac7-4044-8a75-a04e319cdd4f 61 fields · synced May 18, 2026
- EUDAMED 0caef1b7-c521-4b7b-a223-dd9225294f12 61 fields · synced May 19, 2026