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HbA1c plus For the quantitative determination of HbA1c by turbidimetric method

by Spectrum for Diagnostic Industries (Joint Stock Company)

Ref 401 001-M

Active European Union

CE IVDD

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/IVDD NumberB-G458401001M4P Basic UDI-DI G458401001M4PUDI-DIDate25 Aug 2026RegisteredStatusActive

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  • Withdrawn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/IVDD Active

Specification

EUDAMED

Model / Reference
401 001-M
Primary DI / UDI-DI
G458401001M4P
Basic UDI-DI
B-G458401001M4P
EMDN Code
W01010214 Glycosylated/glycated haemoglobin (cc)
Device Class
Class IVD General
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
EG-MF-000033954
Authorised representative
MDSS GmbH DE-AR-000005430

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Properties

  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (6)

  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No