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Glycated Hemoglobin(HbA1c) Detection Kit (Nephelometry)

by Genrui Biotech Inc. 8 variants

Ref 32027156

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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69503348PA041HX Basic UDI-DI 06950334821557UDI-DIDate28 Apr 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference
32027156
Primary DI / UDI-DI
06950334821557
Basic UDI-DI
69503348PA041HX
EMDN Code
W0102060109 Glycosylated/glycated haemoglobin (ic)
Device Class
Class C
EU market of registration
Bulgaria

Manufacturer details

EUDAMED SRN
CN-MF-000017351
Authorised representative
Lotus NL B.V. NL-AR-000000121

From the manufacturer

Manufacturer's product page: LungeKlar® Seven Lung Cancer-associated Autoantibodies Detection Kit (CLIA)

Other devices from Genrui Biotech Inc.

See all devices from Genrui Biotech Inc. →

Properties

  • Reagent
  • Professional Testing

Other properties (9)

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