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Ceramic Ankle Support
EUDAMEDClass I (EU MDR)
Ref 994-TAN-SRef 994-TAN-LRef 994-TAN-MRef 994-TAN-XL
Identity
- Trade Name
- Ceramic Ankle Support EUDAMED
- Device Name
- LOWER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- 994-TAN-S EUDAMED994-TAN-L EUDAMED994-TAN-M EUDAMED994-TAN-XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269537370 EUDAMED00840269537394 EUDAMED00840269537387 EUDAMED00840269537400 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
Ceramic 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 (4)
- EUDAMED c13b717c-10c4-48a3-b5ec-bf521db18acc 61 fields · synced Jul 10, 2026
- EUDAMED 046421a5-14a3-4ca0-820a-18b412645eed 61 fields · synced May 18, 2026
- EUDAMED 3cfc8f89-7d1b-43c3-854d-54059ac25208 61 fields · synced May 18, 2026
- EUDAMED 7146808e-129e-4ee2-9669-4b8d2cf46878 61 fields · synced May 19, 2026