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Coolprene Wrist/Thumb Sleeve
EUDAMEDClass I (EU MDR)
Ref 752CN-TAN-LRef 752CN-BK-LRef 752CN-TAN-XLRef 752CN-BL-SRef 752CN-BL-MRef 752CN-BK-MRef 752CN-BL-XXLRef 752CN-BL-XLRef 752CN-BK-XLRef 752CN-TAN-SRef 752CN-BK-XXL
Identity
- Trade Name
- COOLPRENE WRIST/THUMB SLEEVE EUDAMED
- Device Name
- UPPER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- 752CN-TAN-L EUDAMED752CN-BK-L EUDAMED752CN-TAN-XL EUDAMED752CN-BL-S EUDAMED752CN-BL-M EUDAMED752CN-BK-M EUDAMED752CN-BL-XXL EUDAMED752CN-BL-XL EUDAMED752CN-BK-XL EUDAMED752CN-TAN-S EUDAMED752CN-BK-XXL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269526954 EUDAMED00840269526855 EUDAMED00840269526961 EUDAMED00840269526886 EUDAMED00840269526893 EUDAMED00840269526848 EUDAMED00840269526923 EUDAMED00840269526916 EUDAMED00840269526862 EUDAMED00840269526930 EUDAMED00840269526879 EUDAMED
- Basic UDI-DI
- 08402695CL1038G EUDAMED
- EMDN Code
- Y060699 ORTHOSES, UPPER EXTREMITY - 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 Wrist/Thumb Sleeve 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 | 08402695CL1038G | 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 (11)
- EUDAMED 2d221850-076d-492f-bb8b-ec2f4fb42101 61 fields · synced Sep 18, 2026
- EUDAMED 384e7043-7e1b-4696-86cd-774798976ecb 61 fields · synced May 16, 2026
- EUDAMED 50fcb459-5edf-49cb-9f8f-113cc61b3a24 61 fields · synced May 16, 2026
- EUDAMED d1aa1689-db16-4cc8-93c4-480ec6d2e3b6 61 fields · synced May 17, 2026
- EUDAMED 8e4babb8-c273-4108-8250-682b4a1e4937 61 fields · synced May 17, 2026
- EUDAMED 5a5fd465-8cfb-4829-ae24-7dd9ee262c46 61 fields · synced May 17, 2026
- EUDAMED 4a35538d-bf41-4688-99ab-1652cd37d8bd 61 fields · synced May 18, 2026
- EUDAMED 7f60f043-8ce7-4db8-a070-f5ebd3a12686 61 fields · synced May 18, 2026
- EUDAMED ddc22c08-e6db-40b2-9798-37ee095a471a 61 fields · synced May 18, 2026
- EUDAMED 689dc995-3882-4120-b010-8d4559a7ac44 61 fields · synced May 18, 2026
- EUDAMED f81c3cb0-a40f-4848-b822-a164ce614cb2 61 fields · synced May 19, 2026