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Adjustable Ankle Support
EUDAMEDClass I (EU MDR)
Ref 768-BL-MRef 768KM-BK-XLRef 768-BL-XLRef 768-BL-LRef 768-BK-MRef 768KM-BK-SRef 768-TAN-M
Identity
- Trade Name
- Adjustable Ankle Support EUDAMED
- Device Name
- LOWER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- 768-BL-M EUDAMED768KM-BK-XL EUDAMED768-BL-XL EUDAMED768-BL-L EUDAMED768-BK-M EUDAMED768KM-BK-S EUDAMED768-TAN-M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269521584 EUDAMED00840269501883 EUDAMED00840269521645 EUDAMED00840269521614 EUDAMED00840269521577 EUDAMED00840269501852 EUDAMED00840269521591 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
Adjustable Ankle 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 | 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 (7)
- EUDAMED 7b07318b-3800-4368-8a0e-949ad6b3c94d 61 fields · synced Jul 26, 2026
- EUDAMED 32b8d41f-4faa-4155-b5af-9b4cd517f48c 61 fields · synced May 17, 2026
- EUDAMED b03e632b-6ae5-4248-834b-65a1a808324b 61 fields · synced May 17, 2026
- EUDAMED a6ffe67a-aa46-4666-a4b3-85f2ee623f96 61 fields · synced May 17, 2026
- EUDAMED b509b563-adfa-4d1e-94de-2959be46ee06 61 fields · synced May 17, 2026
- EUDAMED eff04bf9-0540-4c60-be99-252e7e6f215f 61 fields · synced May 18, 2026
- EUDAMED 1dfd72ee-786f-4305-b911-04839e7302c6 61 fields · synced May 18, 2026