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Achilles Tendon Support
EUDAMEDClass I (EU MDR)
Ref 529-L-BK-SRef 529-R-BK-SRef 529-R-BK-LRef 529-L-BK-L
Identity
- Trade Name
- Achilles Tendon Support EUDAMED
- Device Name
- LOWER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- 529-L-BK-S EUDAMED529-R-BK-S EUDAMED529-R-BK-L EUDAMED529-L-BK-L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269510328 EUDAMED00840269510311 EUDAMED00840269510359 EUDAMED00840269510366 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
Achilles Tendon 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 (4)
- EUDAMED d96e7abf-95da-4e6a-8ede-83c0fc618b56 61 fields · synced Sep 30, 2026
- EUDAMED b8dfad6d-be6a-4589-93b0-70c2e0fe3421 61 fields · synced May 18, 2026
- EUDAMED 556cdf5b-6317-4baf-8a9f-deaac6489b6e 61 fields · synced May 19, 2026
- EUDAMED 2c00b74a-84d3-420a-ac48-8df6386c440a 61 fields · synced May 19, 2026