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ComboStik 11

by DFI Co., Ltd.

Ref 2A64Model ComboStik Series

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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number88061413US32D0JH Basic UDI-DI 08806141304654UDI-DIDate12 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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, 2A64
Primary DI / UDI-DI
08806141304654
Basic UDI-DI
88061413US32D0JH
EMDN Code
W01010999 Multiple parameters urine testing - other
Device Class
Class B
EU market of registration
Germany

Manufacturer details

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

Other devices from DFI Co., Ltd.

See all devices from DFI Co., Ltd. →

Properties

  • Professional Testing

Other properties (10)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No