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Over Shoulder Humeral Splint
EUDAMEDClass I (EU MDR)
Ref MSH0061 (XL/UNI/WH)Model Shoulder Brace Series
Identity
- Trade Name
- Over Shoulder Humeral Splint EUDAMED
- Device Name
- Shoulder strap orthosis and tubular support bandage EUDAMED
- Model / Reference
- Shoulder Brace Series EUDAMEDMSH0061 (XL/UNI/WH) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710374232193 EUDAMED
- Basic UDI-DI
- 471230298SHRG 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
Over Shoulder Humeral Splint 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 | 471230298SHRG | 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 7f5e8c45-1c48-48e7-bd47-c272a74cbf1e 61 fields · synced Jun 19, 2026