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Light Shield Adjustable Ankle Brace
EUDAMEDClass I (EU MDR)
Ref CT12-RD-L/XLRef CT12-BL-S/MRef CT12-SV-S/M
Identity
- Trade Name
- Light Shield Adjustable Ankle Brace EUDAMED
- Device Name
- LOWER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- CT12-RD-L/XL EUDAMEDCT12-BL-S/M EUDAMEDCT12-SV-S/M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269527470 EUDAMED00840269527425 EUDAMED00840269527449 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
Light Shield Adjustable Ankle Brace 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 a6f21813-c662-4c10-9a35-3f6bf94c295d 61 fields · synced Jul 13, 2026
- EUDAMED 0dccfb48-8b26-405a-90df-7ff0585c9e6a 61 fields · synced May 18, 2026
- EUDAMED ded8f878-360c-456b-805c-058427156f7a 61 fields · synced May 18, 2026