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Ankle Support 1.0
EUDAMEDClass I (EU MDR)
Ref 110XT-BK-MRef 110XT-BK-XLRef 110XT-BK-S
Identity
- Trade Name
- Ankle Support 1.0 EUDAMED
- Device Name
- LOWER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- 110XT-BK-M EUDAMED110XT-BK-XL EUDAMED110XT-BK-S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269537028 EUDAMED00840269504907 EUDAMED00840269504884 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
Ankle Support 1.0 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 (3)
- EUDAMED edf64427-7039-421b-9534-6cdd25fd8359 61 fields · synced Jul 26, 2026
- EUDAMED c26150d1-24a5-429f-bfa9-3f4c5eb4a453 61 fields · synced May 18, 2026
- EUDAMED 284cee09-68a1-4ddc-895b-d74100a0b41c 61 fields · synced May 19, 2026