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ComboStik 5L

by DFI Co., Ltd.

Part of a family of 14 devices: see the family page

Ref 2534Model ComboStik Series

ComboStik 5L (2534) is a Class B device made by DFI Co., Ltd., registered in EUDAMED on 12 May 2026 (Basic UDI-DI 88061413US32D0JH), 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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number88061413US32D0JH Basic UDI-DI 08806141304692UDI-DIDate12 May 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Device name
ComboStik Series
Model / reference
ComboStik Series, 2534
Primary DI / UDI-DI
08806141304692
Basic UDI-DI
88061413US32D0JH
EMDN code
W01010999 Multiple parameters urine testing - other
Device class
Class B
EU registration type
Standard device
EU market of registration
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)