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Xceed Saliva DNA Collection kit

by Institute of Applied Biotechnologies a.s.

Ref IAS0100.01

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, 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/IVDR Number859422216000IAS01009G Basic UDI-DI 08594222160007UDI-DIDate7 Sep 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  • Withdrawn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/IVDR Active

Specification

EUDAMED

Model / Reference
IAS0100.01
Primary DI / UDI-DI
08594222160007
Basic UDI-DI
859422216000IAS01009G
Direct Marketing DI
08594222160007
EMDN Code
W02050199 Nucleic acid testing instruments except micro-arrays - other
Device Class
Class A
EU market of registration
Czechia

Manufacturer details

EUDAMED SRN
CZ-MF-000042231

Other devices from Institute of Applied Biotechnologies a.s.

Properties

  • Companion Diagnostics

Other properties (10)

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