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Glycohemoglobin Analyzer

by Shinva Medical Instrument Co., Ltd. 3 variants

Ref SGH-400Model SGH-200、SGH-400、SGH-310

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697061496200003QR Basic UDI-DI 06970614968444UDI-DIDate4 Dec 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference
SGH-200、SGH-400、SGH-310, SGH-400
Primary DI / UDI-DI
06970614968444
Basic UDI-DI
697061496200003QR
Direct Marketing DI
06970614968444
EMDN Code
W0201050201 High performance liquid chromatography systems
Device Class
Class A
EU market of registration
Croatia

Manufacturer details

EUDAMED SRN
CN-MF-000009856
Authorised representative
Eunitor GmbH DE-AR-000005081

Other devices from Shinva Medical Instrument Co., Ltd.

See all devices from Shinva Medical Instrument Co., Ltd. →

Properties

  • Surgical Instrument

Other properties (10)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • New Device: No