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Coolprene Ankle Sleeve With Open Heel
EUDAMEDClass I (EU MDR)
Ref 704CN-BL-XLRef 704CN-TAN-XLRef 704CN-BL-LRef 704CN-BK-XXLRef 704CN-BL-SRef 704CN-BK-XLRef FT15CA-BK-MRef 704CN-TAN-XXL
Identity
- Trade Name
- COOLPRENE ANKLE SLEEVE WITH OPEN HEEL EUDAMEDCOOLPRENE X Ankle Sleeve with Open Heel EUDAMED
- Device Name
- LOWER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- 704CN-BL-XL EUDAMED704CN-TAN-XL EUDAMED704CN-BL-L EUDAMED704CN-BK-XXL EUDAMED704CN-BL-S EUDAMED704CN-BK-XL EUDAMEDFT15CA-BK-M EUDAMED704CN-TAN-XXL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269525773 EUDAMED00840269525834 EUDAMED00840269525766 EUDAMED00840269525728 EUDAMED00840269525742 EUDAMED00840269525711 EUDAMED00840269506949 EUDAMED00840269525841 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 Ankle Sleeve With Open Heel 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 44c2837b-2792-43e9-8041-5acbf530db57 61 fields · synced Sep 18, 2026
- EUDAMED 21febf56-0b99-4c02-a2a1-6b88fe7a66ed 61 fields · synced May 16, 2026
- EUDAMED 06c15286-0b0a-40f8-8934-c991ea8adae6 61 fields · synced May 17, 2026
- EUDAMED 21d7ae71-c5df-432a-9f97-180b08056808 61 fields · synced May 18, 2026
- EUDAMED ea353aad-a970-4d24-b713-968e65b677fe 61 fields · synced May 18, 2026
- EUDAMED 72a8b8c0-1268-4da4-9072-8420139085c2 61 fields · synced May 18, 2026
- EUDAMED 1023ddda-cdb9-4b37-b9b4-1cd1b133f4a2 61 fields · synced May 18, 2026
- EUDAMED 7ee54eed-ec17-467a-af52-e0b110e91530 61 fields · synced May 18, 2026