KWIK-STIK™ and LYFO DISK™

by Microbiologics, INC. 1,000+ variants

Ref [0660K] KWIK-STIK™ T. pyogenes ATCC 19411™Model 0660

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	Number084535700660A4 Basic UDI-DI 30845357015687UDI-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Withdrawn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: 0660, [0660K] KWIK-STIK™ T. pyogenes ATCC 19411™

Primary DI / UDI-DI: 30845357015687
Basic UDI-DI: 084535700660A4
EMDN Code: W01040601 Qc strains bacteriology

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