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Coolprene Elbow Sleeve
EUDAMEDClass I (EU MDR)
Ref 702CN-BK-MRef 702CN-BK-XXLRef 702CN-BL-XLRef 702CN-TAN-LRef 702CN-TAN-XXLRef 702CN-BK-XLRef 702CN-BL-MRef 702CN-BK-SRef 702CN-BK-L
Identity
- Trade Name
- COOLPRENE ELBOW SLEEVE EUDAMED
- Device Name
- UPPER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- 702CN-BK-M EUDAMED702CN-BK-XXL EUDAMED702CN-BL-XL EUDAMED702CN-TAN-L EUDAMED702CN-TAN-XXL EUDAMED702CN-BK-XL EUDAMED702CN-BL-M EUDAMED702CN-BK-S EUDAMED702CN-BK-L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269525360 EUDAMED00840269525391 EUDAMED00840269525445 EUDAMED00840269525490 EUDAMED00840269525513 EUDAMED00840269525384 EUDAMED00840269525421 EUDAMED00840269525353 EUDAMED00840269525377 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 Elbow 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 (9)
- EUDAMED f2515080-c565-42d5-b65f-6e27cd7a461b 61 fields · synced Aug 3, 2026
- EUDAMED 0dbc0a72-cf9e-4330-97c4-82e2eb2a79b0 61 fields · synced May 17, 2026
- EUDAMED 4a8429e8-dd09-4bbc-b447-fbff9ce3a7d3 61 fields · synced May 17, 2026
- EUDAMED e61ee896-bbca-48d7-a8b9-0d1cc8906010 61 fields · synced May 17, 2026
- EUDAMED 0c1b9bb9-f991-4076-8805-c95d13f37388 61 fields · synced May 17, 2026
- EUDAMED f60376d5-7d80-4fed-ac22-9ed556cb1e64 61 fields · synced May 18, 2026
- EUDAMED 5d5eadf8-9194-456d-946a-10c03344b27a 61 fields · synced May 18, 2026
- EUDAMED 4248e5e4-0e8e-4d0a-9bb8-3addd2950c11 61 fields · synced May 18, 2026
- EUDAMED 6cc4773d-f9c1-4084-bd27-436821e05634 61 fields · synced May 18, 2026