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System III Slotted Cassette -Green (Loose Inkjet)

by CellPath Ltd

Ref EAI-0204-10A

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 Number05056256EAI001XS Basic UDI-DI 05056256101218UDI-DIDate18 Jul 2022RegisteredStatusActive

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  • Withdrawn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
System III Cassette
Model / Reference
EAI-0204-10A
Primary DI / UDI-DI
05056256101218
Basic UDI-DI
05056256EAI001XS
EMDN Code
W0202050385 Laboratory instruments for microscopic investigations - consumables
Device Class
Class A
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
GB-MF-000022744
Authorised representative
Emergo Europe B.V. NL-AR-000000116

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Properties

  • Surgical Instrument

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
  • Companion Diagnostics: No
  • New Device: No