Skip to content

Cybow 12AC

by DFI Co., Ltd.

Part of a family of 20 devices: see the family page

Ref 4B04Model CYBOW Series

Cybow 12AC (4B04) is a device classified as IVD General (EU), Class B (EU) made by DFI Co., Ltd., registered in EUDAMED on 14 May 2026 (Basic UDI-DI B-KR-MF-000015786PROCYU7), active as of 22 Oct 2026.

Active European Union

CE IVDR CE IVDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-KR-MF-000015786PROCYU7 Basic UDI-DI Date14 May 2026RegisteredStatusActive
European UnionCE/IVDD NumberB-KR-MF-000015786PROCYU7 Basic UDI-DI Date14 May 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR, CE/IVDD Active

Specification

EUDAMED

Device name
CYBOW Series
Model / reference
CYBOW Series, 4B04
Primary DI / UDI-DI
D-KR-MF-000015786PROCYU7, 08806141304463
Basic UDI-DI
B-KR-MF-000015786PROCYU7, 88061413US31D0JC
EMDN code
W01010999 Multiple parameters urine testing - other
Device class
Class IVD General
Class B
EU registration type
Legacy device (under a directive)
Standard device
EU market of registration
France
Germany

Manufacturer details

EUDAMED SRN
KR-MF-000015786
Authorised representative
MDSS GmbH DE-AR-000005430

Similar devices in this category

Other devices filed under MULTIPLE PARAMETERS URINE TESTING - OTHER.

Other devices from DFI Co., Ltd.

See all devices from DFI Co., Ltd. →

Properties

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