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Thermo Ankle Support
EUDAMEDClass I (EU MDR)
Ref SANTM60 (L/UNI/BK)Model Ankle Brace Series
Identity
- Trade Name
- Thermo Ankle Support EUDAMED
- Device Name
- Ankle/foot orthosis and tubular support bandage EUDAMED
- Model / Reference
- Ankle Brace Series EUDAMEDSANTM60 (L/UNI/BK) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719961401516 EUDAMED
- Basic UDI-DI
- 471230298ANQ6 EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Category: Ankle/foot orthosis
Thermo Ankle Support by e-life International Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Ankle/foot orthosis.
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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 | 471230298ANQ6 | Class I | Active |
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Manufacturer
- Manufacturer
- e-life International Co., Ltd.
- EUDAMED SRN
- TW-MF-000009901
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 21fe4eff-2283-4164-a59b-4a738d29b99e 61 fields · synced Jun 19, 2026