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Total Iron and Total Iron Binding Capacity Reagent set

by Spectrum for Diagnostic Industries (Joint Stock Company)

Ref 270 001

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-G458270001ZM Basic UDI-DI G458270001ZMUDI-DIDate9 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  • Withdrawn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
270 001
Primary DI / UDI-DI
G458270001ZM
Basic UDI-DI
B-G458270001ZM
EMDN Code
W01010217 Iron binding capacity - total (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

Other devices from Spectrum for Diagnostic Industries (Joint Stock Company)

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Properties

  • Reagent
  • Professional Testing

Other properties (8)

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