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KWIK-STIK™ and LYFO DISK™
EUDAMEDClass B (EU MDR)
Ref [0710P] KWIK-STIK™ S. agalactiae (B) NCTC 9993Model 0710
Identity
- Device Name
- KWIK-STIK™ and LYFO DISK™ EUDAMED
- Model / Reference
- 0710 EUDAMED[0710P] KWIK-STIK™ S. agalactiae (B) NCTC 9993 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 20845357017158 EUDAMED
- Basic UDI-DI
- 0845357007109S 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
KWIK-STIK™ and LYFO DISK™ by Microbiologics, Inc. — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 0845357007109S | Class B | Active |
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Manufacturer
- Manufacturer
- Microbiologics, INC.
- EUDAMED SRN
- US-MF-000000466
- Authorised Representative
- MediMark Europe Sarl. FR-AR-000000182
Sources (1)
- EUDAMED 5d5b3a8d-69c8-4d34-a354-fd7693e25e3e 61 fields · synced Jun 18, 2026