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Glycated Hemoglobin Reagent (HPLC)

by Shinva Medical Instrument Co., Ltd. China EUDAMED

Ref 02002-07Model Type A、Type B、Type C-200 tests、Type C-400 tests、Type C-600 tests、Type D-200 tests、Type D-400 tests、Type D-600 tests EMDN W01019001

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697061496200001QM Basic UDI-DIDate21 Nov 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  • Withdrawn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 25 Oct 2026

Device Name
Glycated Hemoglobin Reagent (HPLC)
Model / Reference
Type A、Type B、Type C-200 tests、Type C-400 tests、Type C-600 tests、Type D-200 tests、Type D-400 tests、Type D-600 tests, 02002-07
Primary DI / UDI-DI
06970614969724
Basic UDI-DI
697061496200001QM
EMDN Code
W01019001 Buffers (unassignable), supplem. reagents, etc (cc)
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
  • Reagent
Other properties (10)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 06970614969724|697061496200001QM 61 fields · synced 25 Oct 2026