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STI7-Q Real-Time PCR Kit
EUDAMEDClass IVD General (EU MDR)
Ref G2M709121,G2M709121RModel G2M709121
Identity
- Trade Name
- STI7-Q Real-Time PCR Kit EUDAMED
- Device Name
- STI7-Q Real-Time PCR Kit EUDAMED
- Model / Reference
- G2M709121 EUDAMEDG2M709121,G2M709121R EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-G2M709121FX EUDAMED
- Basic UDI-DI
- B-G2M709121FX EUDAMED
- EMDN Code
- W0105070501 STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Belgium 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
STI7-Q Real-Time PCR Kit by Genes 2Me Private Limited — 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-G2M709121FX | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Genes 2Me Private Limited
- EUDAMED SRN
- IN-MF-000035953
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED dc9e6b4a-f2e0-4712-aaf3-b1da776b8579 61 fields · synced Aug 3, 2026
- EUDAMED dc9e6b4a-f2e0-4712-aaf3-b1da776b8579-1 61 fields · synced Jun 9, 2026