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Ige Türbi̇di̇metri̇k Kali̇bratör Set

by Archem Sağlik Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇

Ref 01R99-01

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08699015281850 Basic UDI-DI 08699015281850UDI-DIDate3 Jul 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  • Withdrawn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

Device Name
Ige Turbidimetric Calibrator Set
Model / Reference
01R99-01
Primary DI / UDI-DI
08699015281850
Basic UDI-DI
B-08699015281850
EMDN Code
W0101050302 Calibrators single component (cc)
Device Class
Class IVD General
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000027166

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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