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LyoSens Mycoplasma genitalium qPCR Kit
EUDAMEDClass IVD General (EU MDR)
Ref LYO58Model LYO58WS96
Identity
- Trade Name
- LyoSens Mycoplasma genitalium qPCR Kit EUDAMED
- Device Name
- Mycoplasma genitalium qPCR Kit EUDAMED
- Model / Reference
- LYO58WS96 EUDAMEDLYO58 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08684998275668 EUDAMED
- Basic UDI-DI
- B-08684998275668 EUDAMED
- EMDN Code
- W010501080302 UROGENITAL MYCOPLASMA DETECTION BY NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
LyoSens Mycoplasma genitalium qPCR Kit by Vitrosens Biotechnology Inc. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-08684998275668 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Vitrosens Biotechnology Inc.
- EUDAMED SRN
- TR-MF-000026452
Sources (1)
- EUDAMED d8aa8509-188e-45d7-b553-a9933a1ac349 61 fields · synced Jun 17, 2026