← Back to catalogue
Laced Ankle Brace
EUDAMEDClass I (EU MDR)
Ref MAN0042 (L/UNI/BK)Model Ankle Brace Series
Identity
- Trade Name
- Laced Ankle Brace EUDAMED
- Device Name
- Ankle/foot orthosis and tubular support bandage EUDAMED
- Model / Reference
- Ankle Brace Series EUDAMEDMAN0042 (L/UNI/BK) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04712302982439 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
Laced Ankle Brace by e-life International Co., 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 | 471230298ANQ6 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- e-life International Co., Ltd.
- EUDAMED SRN
- TW-MF-000009901
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 78bc5232-29ed-4c4e-a1a1-842523716a38 61 fields · synced Jun 18, 2026