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Universal Lacing Wrist Brace
EUDAMEDClass I (EU MDR)
Ref 2005Model Upper Limb Orthoses
Identity
- Trade Name
- Universal Lacing Wrist Brace EUDAMED
- Model / Reference
- Upper Limb Orthoses EUDAMED2005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978867216459 EUDAMED
- Basic UDI-DI
- 697886721UO000U8 EUDAMED
- Direct Marketing DI
- 06978867216459 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
Universal Lacing Wrist 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 c05ee2a0-b306-43bc-8916-fee90f1316db 61 fields · synced Jun 18, 2026