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Arm Abduction Brace
EUDAMEDClass I (EU MDR)
Ref TJ-201Model Upper Limb Orthoses
Identity
- Trade Name
- Arm Abduction Brace EUDAMED
- Model / Reference
- Upper Limb Orthoses EUDAMEDTJ-201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978867216336 EUDAMED
- Basic UDI-DI
- 697886721UO000U8 EUDAMED
- Direct Marketing DI
- 06978867216336 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 Brace 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 f87cdb69-59d3-4db8-813c-e94a1f215563 61 fields · synced Jun 18, 2026