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Coolprene Knee Sleeve
EUDAMEDClass I (EU MDR)
Ref 706CN-TAN-XXLRef 706CN-BL-XSRef 706CN-BK-LRef FT75CA-BK-LRef 706CN-TAN-LRef 706CN-BK-XLRef 706CN-BL-LRef 706CN-BL-MRef 706CN-BK-XXLRef 706CN-BL-XXLRef 706CN-BK-XSRef 706CN-TAN-M
Identity
- Trade Name
- COOLPRENE KNEE SLEEVE EUDAMEDCOOLPRENE X Knee Sleeve EUDAMED
- Device Name
- LOWER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- 706CN-TAN-XXL EUDAMED706CN-BL-XS EUDAMED706CN-BK-L EUDAMEDFT75CA-BK-L EUDAMED706CN-TAN-L EUDAMED706CN-BK-XL EUDAMED706CN-BL-L EUDAMED706CN-BL-M EUDAMED706CN-BK-XXL EUDAMED706CN-BL-XXL EUDAMED706CN-BK-XS EUDAMED706CN-TAN-M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269526107 EUDAMED00840269525995 EUDAMED00840269525964 EUDAMED00840269507489 EUDAMED00840269526084 EUDAMED00840269525971 EUDAMED00840269526022 EUDAMED00840269526015 EUDAMED00840269525988 EUDAMED00840269526046 EUDAMED00840269525933 EUDAMED00840269526077 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 Knee 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 | 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 (12)
- EUDAMED 18540d3e-9d20-407c-8bf8-e942bc77ab85 61 fields · synced Sep 18, 2026
- EUDAMED 2f06374e-b75b-4500-b5ff-815e52790fda 61 fields · synced May 17, 2026
- EUDAMED 050b8660-0b3a-4bf1-ad86-28bebba9575e 61 fields · synced May 17, 2026
- EUDAMED 4b5cab5e-b1a2-43b6-ac9b-434a85626d9d 61 fields · synced May 17, 2026
- EUDAMED f0d1b540-0a8d-4c3a-a4c7-3dcf0326829b 61 fields · synced May 17, 2026
- EUDAMED f7079efa-c615-4a15-9c8f-769d53dd7bf2 61 fields · synced May 17, 2026
- EUDAMED 8ea8d715-359e-47b5-bbd8-8d6a81d7ddc2 61 fields · synced May 18, 2026
- EUDAMED 857e789f-1517-418a-8d23-9d21cda3fb53 61 fields · synced May 18, 2026
- EUDAMED b047883a-6ab3-467c-8519-895a92d08d8e 61 fields · synced May 18, 2026
- EUDAMED 2226f060-9369-454f-8eda-254547bae825 61 fields · synced May 18, 2026
- EUDAMED 795cb629-5757-49c8-bfcd-6e7bfcc2a67d 61 fields · synced May 18, 2026
- EUDAMED 3b3080a7-41db-4019-a998-526d52eabc18 61 fields · synced May 19, 2026