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Glycated Hemoglobin Reagent (HPLC)
EUDAMEDClass A (EU MDR)
Ref 02002-01Model Type A、Type BRef 02002-02
Identity
- Device Name
- Glycated Hemoglobin Reagent (HPLC) EUDAMED
- Model / Reference
- Type A、Type B EUDAMED02002-01 EUDAMED02002-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970614968390 EUDAMED06970614968406 EUDAMED
- Basic UDI-DI
- 697061496200001QM EUDAMED
- EMDN Code
- W01019001 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Croatia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Glycated Hemoglobin Reagent (HPLC) by Shinva Medical Instrument Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697061496200001QM | Class A | Active |
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Manufacturer
- Manufacturer
- Shinva Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000009856
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (2)
- EUDAMED af11e26d-e194-4eba-b5f5-50129a31b57d 61 fields · synced Sep 18, 2026
- EUDAMED 4096c3ef-c942-484c-9137-14d5d5e9281c 61 fields · synced May 17, 2026