Skip to content

HURO PATH® Filter

by CelltraZone Co., Ltd

Ref AFSTD001Model HURO PATH® Filter

HURO PATH Filter (AFSTD001) is an in vitro diagnostic device (EU IVDR Class A) made by CelltraZone Co., Ltd, registered in EUDAMED on 17 Oct 2025 (Basic UDI-DI 88000385CZFILM2), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number88000385CZFILM2 Basic UDI-DI 08800038500419UDI-DIDate17 Oct 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  • Withdrawn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
Slide Sample Processor
Model / reference
AFSTD001, HURO PATH® Filter
Primary DI / UDI-DI
08800038500419
Basic UDI-DI
88000385CZFILM2, 88000385CZFSTDNZ
Direct marketing DI
08800038500419
EMDN code
W02069099, W02069085
Device class
Class A
EU registration type
Standard device
EU market of registration
Hungary

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 devices from CelltraZone Co., Ltd

See all devices from CelltraZone Co., Ltd →

Properties

  • Professional testing
Other properties (12, all answered No)