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Malleogib Fast S1
EUDAMEDClass I (EU MDR)
Ref 6769/ MANQF03 (T1/ 17-21)Model Ankle Brace Series
Identity
- Trade Name
- Malleogib Fast S1 EUDAMED
- Device Name
- Ankle/foot orthosis and tubular support bandage EUDAMED
- Model / Reference
- Ankle Brace Series EUDAMED6769/ MANQF03 (T1/ 17-21) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719961411058 EUDAMED
- Basic UDI-DI
- 471230298ANQ6 EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Malleogib Fast S1 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 34c598ea-2132-45e9-bdb8-32f00c2f2089 61 fields · synced Jul 21, 2026