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CitoDx CBC Analyzer

by CytoChip Inc.

Ref 1130

CitoDx CBC Analyzer (1130) is a Class A device made by Cytochip, Inc., registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI 08500637511130HF), active as of 7 Nov 2026.

Active European Union

CE IVDR

Valid until

No date given

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

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number08500637511130HF Basic UDI-DI 00850063751131UDI-DIDate29 Oct 2026RegisteredStatusActive

Official records

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  • Withdrawn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
1130
Primary DI / UDI-DI
00850063751131
Basic UDI-DI
08500637511130HF
Direct marketing DI
00850063751131
EMDN code
W0202010101 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
Device class
Class A
EU registration type
Standard device
EU market of registration
France

Manufacturer details

EUDAMED SRN
US-MF-000043146
Authorised representative
Medunion S.L. ES-AR-000019366

Similar devices in this category

Other devices filed under AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr).

Other devices from Cytochip, Inc.

Properties

  • Near-patient testing
  • Professional testing
  • IVD instrument
Other properties (10, all answered No)