Skip to content

Glycohemoglobin Analyzer

by Shinva Medical Instrument Co., Ltd. China EUDAMED

Ref SGH-310Model SGH-200、SGH-400、SGH-310 EMDN W0201050201

Regulatory status

as of 25 Oct 2026

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

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
SGH-200、SGH-400、SGH-310, SGH-310
Primary DI / UDI-DI
06970614968130
Basic UDI-DI
697061496200003QR
Direct Marketing DI
06970614968130
EMDN Code
W0201050201 High performance liquid chromatography systems
Device Class
Class A
Market of Registration
Spain

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 & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 06970614968130|697061496200003QR 61 fields · synced 23 Oct 2026