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Xceed Blood DNA and cfDNA Collection kit

by Institute of Applied Biotechnologies a.s. 2 variants

Ref IAF0100.01

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number859422216000IAF01004Z Basic UDI-DI 08594222160038UDI-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  • Withdrawn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

Device Name
Xceed Dry Blood Collection Card
Model / Reference
IAF0100.01
Primary DI / UDI-DI
08594222160038
Basic UDI-DI
859422216000IAF01004Z
Direct Marketing DI
08594222160038
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