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Arthritis Gloves
EUDAMEDClass I (EU MDR)
Ref AG11Model AG11，AG-12，AG-13，AG-14，AG-15，AG-16，AG-17，AG-18，AG-19，AG-110，AG-111，AG-112，AG-113，AG-114，AG-115，AG-116，AG-117，AG-118，AG-121
Identity
- Device Name
- Arthritis Gloves EUDAMED
- Model / Reference
- AG11，AG-12，AG-13，AG-14，AG-15，AG-16，AG-17，AG-18，AG-19，AG-110，AG-111，AG-112，AG-113，AG-114，AG-115，AG-116，AG-117，AG-118，AG-121 EUDAMEDAG11 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979884281857 EUDAMED
- Basic UDI-DI
- 697988428AG001P5 EUDAMED
- EMDN Code
- Y060612 WRIST-HAND ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Arthritis Gloves by Shenzhen QiJiang Technology 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 | 697988428AG001P5 | Class I | Active |
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Manufacturer
- Manufacturer
- Shenzhen QiJiang Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000042530
- Authorised Representative
- REP Europe GmbH DE-AR-000025090
Sources (1)
- EUDAMED a41126a6-f5a9-40d1-af69-c5f74526c034 61 fields · synced Jun 19, 2026