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Glycohemoglobin Analyzer
EUDAMEDClass A (EU MDR)
Ref SGH-200Model SGH-200、SGH-400Ref SGH-400
Identity
- Device Name
- Glycohemoglobin Analyzer EUDAMED
- Model / Reference
- SGH-200、SGH-400 EUDAMEDSGH-200 EUDAMEDSGH-400 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970614968437 EUDAMED06970614968444 EUDAMED
- Basic UDI-DI
- 697061496200003QR EUDAMED
- EMDN Code
- W0201050201 HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS 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
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Glycohemoglobin Analyzer 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 | 697061496200003QR | 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 f071ef97-f7ac-4699-849a-6e05d6bc93a3 61 fields · synced Jul 30, 2026
- EUDAMED 85a51aaf-ebf9-4e64-acc8-2ea70c85bc14 61 fields · synced May 19, 2026