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Coolprene Shoulder Support
EUDAMEDClass I (EU MDR)
Ref 738CN-TAN-SRef 738CN-TAN-XLRef 738CN-TAN-L
Identity
- Trade Name
- COOLPRENE SHOULDER SUPPORT EUDAMED
- Device Name
- UPPER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- 738CN-TAN-S EUDAMED738CN-TAN-XL EUDAMED738CN-TAN-L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269526794 EUDAMED00840269526824 EUDAMED00840269526817 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 Shoulder Support 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 (3)
- EUDAMED 20f24413-82be-44a4-af86-1d2eb703996c 61 fields · synced Jul 18, 2026
- EUDAMED bc0da5a9-6d21-4d87-8382-aab586d99450 61 fields · synced May 17, 2026
- EUDAMED 4e59fcb3-40d8-4377-8c4b-a4f745817d57 61 fields · synced May 18, 2026