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Glycated Hemoglobin Reagent (HPLC)

by Shinva Medical Instrument Co., Ltd. 7 variants

Ref 02002-03Model 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

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697061496200001QM Basic UDI-DI 06970614969687UDI-DIDate21 Nov 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  • Withdrawn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

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, 02002-03
Primary DI / UDI-DI
06970614969687
Basic UDI-DI
697061496200001QM
EMDN Code
W01019001 Buffers (unassignable), supplem. reagents, etc (cc)
Device Class
Class A
EU 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

  • 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