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Ankle Support (With Strap)
EUDAMEDClass I (EU MDR)
Ref 728-BK-XLRef 728-BL-XLRef 728-BK-LRef 728-BL-SRef 728-TAN-XL
Identity
- Trade Name
- Ankle Support (With Strap) EUDAMED
- Device Name
- LOWER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- 728-BK-XL EUDAMED728-BL-XL EUDAMED728-BK-L EUDAMED728-BL-S EUDAMED728-TAN-XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269519178 EUDAMED00840269519185 EUDAMED00840269519147 EUDAMED00840269519093 EUDAMED00840269519192 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
Yes
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
Ankle Support (With Strap) 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 (5)
- EUDAMED 076ba78d-96f0-4041-b3a0-6bad3871ac6a 61 fields · synced Jul 14, 2026
- EUDAMED e490c9e3-eb73-436d-a02c-51cc6652ac8a 61 fields · synced May 18, 2026
- EUDAMED 706146d2-bdaa-4cc5-a228-23110cfee913 61 fields · synced May 18, 2026
- EUDAMED a91b0d9b-6720-45e3-9b9b-8b92b149c251 61 fields · synced May 18, 2026
- EUDAMED ef0173df-3507-4f8c-9204-de13384f6801 61 fields · synced May 18, 2026