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Arm Abduction Orthosis
EUDAMEDClass I (EU MDR)
Ref ZSF-1-11Model Upper Limb Orthoses
Identity
- Trade Name
- Arm Abduction Orthosis EUDAMED
- Model / Reference
- Upper Limb Orthoses EUDAMEDZSF-1-11 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978867216329 EUDAMED
- Basic UDI-DI
- 697886721UO000U8 EUDAMED
- Direct Marketing DI
- 06978867216329 EUDAMED
- EMDN Code
- Y060699 ORTHOSES, UPPER EXTREMITY - OTHER 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
Arm Abduction Orthosis by Medi Global Assistive Device 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 | 697886721UO000U8 | Class I | Active |
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Manufacturer
- Manufacturer
- Medi Global Assistive Device Co., Ltd.
- EUDAMED SRN
- CN-MF-000034804
- Authorised Representative
- Humiss International B.V. NL-AR-000001490
Sources (1)
- EUDAMED 2ea3284d-aa08-4fb7-9811-b9371e63b87f 61 fields · synced Jul 8, 2026