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Shoulder Immobilizer
EUDAMEDClass I (EU MDR)
Ref MARFM07 (Universal/UNI/GY)Model Arm Sling Series
Identity
- Trade Name
- Shoulder Immobilizer EUDAMED
- Device Name
- Arm immobilization sling and shoulder strap orthosis EUDAMED
- Model / Reference
- Arm Sling Series EUDAMEDMARFM07 (Universal/UNI/GY) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710374238027 EUDAMED
- Basic UDI-DI
- 471230298ARQE EUDAMED
- EMDN Code
- Y060621 SHOULDER 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
Shoulder Immobilizer 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 | 471230298ARQE | 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 cd5bdd16-9af8-4af7-8247-2d3fc426b132 61 fields · synced Jun 18, 2026