KWIK-STIK™ and LYFO DISK™

by Microbiologics, INC. 1,000+ variants

Ref [01021K] KWIK-STIK™ A. fumigatus ATCC 204305™Model 01021

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	Number0845357001021VY Basic UDI-DI 30845357029486UDI-DI	Date20 Apr 2026Registered	StatusActive

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

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name: KWIK-STIK™ and LYFO DISK™
Model / Reference: 01021, [01021K] KWIK-STIK™ A. fumigatus ATCC 204305™

Primary DI / UDI-DI: 30845357029486
Basic UDI-DI: 0845357001021VY
EMDN Code: W01040699 Controls, standards, calibrators, microbiology - other

Device Class: Class B
EU market of registration: France

Manufacturer details

EUDAMED SRN: US-MF-000000466
Authorised representative: MediMark Europe Sarl. FR-AR-000000182

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Properties

Microbial Substances
Professional Testing

Other properties (9)

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