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E-Prep Plus

by CelltraZone Co., Ltd

Ref ALBCCZ002

E-Prep Plus (ALBCCZ002) is an in vitro diagnostic device (EU IVDR Class A; EMDN category various sample processing instruments) made by CelltraZone Co., Ltd, registered in EUDAMED on 2 Jul 2025 (Basic UDI-DI 88000385CZHUROQ9), active as of 22 Oct 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number88000385CZHUROQ9 Basic UDI-DI 08800038500341UDI-DIDate2 Jul 2025RegisteredStatusActive

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  • Withdrawn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

Device name
Sample Processing Instruments
Model / reference
ALBCCZ002
Primary DI / UDI-DI
08800038500341
Basic UDI-DI
88000385CZHUROQ9, 88000385CZEPREPSM
Direct marketing DI
08800038500341
EMDN code
W02069099 Various sample processing instruments - other
Device class
Class A
EU registration type
Standard device

Manufacturer details

EUDAMED SRN
KR-MF-000026492
Authorised representative
Javitech Consulting GmbH DE-AR-000045915

Similar devices in this category

Other devices filed under VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER.

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Properties

  • Professional testing
  • IVD instrument
Other properties (11, all answered No)