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APTT Reagent with Calcium Chloride (Liquid Stable)

by Fortress Diagnostics Ltd

Ref COAG110A

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 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05060476974422 Basic UDI-DI 05060476974422UDI-DIDate2 Nov 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  • Withdrawn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
COAG110A
Primary DI / UDI-DI
05060476974422
Basic UDI-DI
B-05060476974422
EMDN Code
W0103020102 Activated partial thromboplastin time
Device Class
Class IVD General
EU market of registration
Northern Ireland

Manufacturer details

EUDAMED SRN
XI-MF-000028408

Other devices from Fortress Diagnostics Ltd

See all devices from Fortress Diagnostics Ltd →

Properties

  • Reagent

Other properties (9)

  • 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