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High Performance Ankle Brace
EUDAMEDClass I (EU MDR)
Ref 787-BK-LRef 787-BK-XSRef 787-BK-S
Identity
- Trade Name
- High Performance Ankle Brace EUDAMED
- Device Name
- LOWER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- 787-BK-L EUDAMED787-BK-XS EUDAMED787-BK-S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269522925 EUDAMED00840269522895 EUDAMED00840269522901 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
High Performance 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 4faa5361-431f-4bb2-bb57-975349596625 61 fields · synced Jul 31, 2026
- EUDAMED bace7c7e-651b-42ec-9231-662a287f43ab 61 fields · synced May 17, 2026
- EUDAMED 1118afb8-d5ee-459f-bcd6-a84f4297e13d 61 fields · synced May 19, 2026