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KWIK-STIK™ and LYFO DISK™

EUDAMED

Class B (EU MDR)

Ref [0968P] KWIK-STIK™ E. faecium ATCC 35667™Model 0968

by Microbiologics, INC.

Identity

Device Name
KWIK-STIK™ and LYFO DISK™ EUDAMED
Model / Reference
0968 EUDAMED
[0968P] KWIK-STIK™ E. faecium ATCC 35667™ EUDAMED

Identifiers

Primary DI / UDI-DI
20845357023487 EUDAMED
Basic UDI-DI
084535700968B3 EUDAMED
EMDN Code
W01040601 QC STRAINS BACTERIOLOGY EUDAMED

Classification

Device Class
Class B EUDAMED
Market of Registration
France EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

Yes

EUDAMED

Reagent

No

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

Category: Multiple bacteria species culture isolate identification control IVD, kit

KWIK-STIK™ and LYFO DISK™ by Microbiologics, Inc. — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Multiple bacteria species culture isolate identification control IVD, kit.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

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Manufacturer

Manufacturer
Microbiologics, INC.
EUDAMED SRN
US-MF-000000466
Authorised Representative
MediMark Europe Sarl. FR-AR-000000182

Sources (1)

  • EUDAMED 17770686-be62-4e15-b2ea-3a533e0172f9 61 fields · synced Jun 11, 2026