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COOLPRENE X Knee Sleeve with Open Patella and Extra Patellar Tendon Support
EUDAMEDClass I (EU MDR)
Ref 719CAR1-BK-MRef 719CAR1-BK-L-1Ref 708CAR1-BK-S-1Ref 708CAR1-BK-M-1Ref 719CAR1-BK-M-1Ref 719CAR1-BK-LRef 708CAR1-BK-L-1Ref 719CAR1-BK-XLRef 719CAR1-BK-S-1
Identity
- Trade Name
- COOLPRENE X Knee Sleeve with Open Patella and Extra Patellar Tendon Support EUDAMEDCOOLPRENE X Knee Sleeve with Open Patella EUDAMED
- Device Name
- LOWER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- 719CAR1-BK-M EUDAMED719CAR1-BK-L-1 EUDAMED708CAR1-BK-S-1 EUDAMED708CAR1-BK-M-1 EUDAMED719CAR1-BK-M-1 EUDAMED719CAR1-BK-L EUDAMED708CAR1-BK-L-1 EUDAMED719CAR1-BK-XL EUDAMED719CAR1-BK-S-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269505553 EUDAMED04719890078728 EUDAMED04719890078667 EUDAMED04719890078674 EUDAMED04719890078711 EUDAMED00840269505560 EUDAMED04719890078681 EUDAMED00840269505577 EUDAMED04719890078704 EUDAMED
- Basic UDI-DI
- 08402695CL1028E EUDAMED471988489CL102GJ EUDAMED
- EMDN Code
- Y061299 LOWER EXTREMITY ORTHOSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMEDMalta 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 Knee Sleeve with Open Patella and Extra Patellar Tendon Support 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 | 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 (9)
- EUDAMED 9655c08e-560c-4d77-b89e-b5c08ea21652 61 fields · synced Jul 28, 2026
- EUDAMED 7501b256-b883-4466-9d64-06ff73d33a11 61 fields · synced May 16, 2026
- EUDAMED c26b3f51-fc00-4cb4-9e2c-9515f10f8d7c 61 fields · synced May 16, 2026
- EUDAMED 8ae981fc-5e26-4c42-97ff-a302446153c5 61 fields · synced May 18, 2026
- EUDAMED af1a8128-3539-48fc-ab4c-c78fab75350d 61 fields · synced May 18, 2026
- EUDAMED 20f574c5-b863-486d-a823-b6c62c45de54 61 fields · synced May 18, 2026
- EUDAMED fdec4e31-0001-4f1c-8e99-e394f82ce8f5 61 fields · synced May 18, 2026
- EUDAMED cdac0317-ff49-4797-88e9-a505ab9702fc 61 fields · synced May 19, 2026
- EUDAMED 6bddfec6-63b6-4184-a0a2-a46d8455be18 61 fields · synced May 19, 2026