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Mycoplasma genitalium/Mycoplasma hominis/Trichomonas vaginalis Nucleic Acid Dia…
EUDAMEDClass IVD General (EU MDR)
Ref S3250E-24-PRef S3250E-48Ref S3250E-12-S
Identity
- Device Name
- Mycoplasma genitalium/Mycoplasma hominis/Trichomonas vaginalis Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) EUDAMED
- Model / Reference
- S3250E-24-P EUDAMEDS3250E-48 EUDAMEDS3250E-12-S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792731752 EUDAMED06955792731745 EUDAMED06955792714625 EUDAMED
- Basic UDI-DI
- B-06955792731752 EUDAMEDB-06955792731745 EUDAMEDB-06955792714625 EUDAMED
- EMDN Code
- W0105070599 MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Portugal EUDAMEDFrance EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
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
Mycoplasma genitalium/Mycoplasma hominis/Trichomonas vaginalis Nucleic Acid Dia… by Sansure Biotech Inc. — Class IVD General — IVDD — listed in EUDAMED
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-06955792731752 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Sansure Biotech Inc.
- EUDAMED SRN
- CN-MF-000011392
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (3)
- EUDAMED 19ec1652-e471-4625-8c74-f5ca93035bff 61 fields · synced Oct 6, 2026
- EUDAMED 4f722599-3350-4673-9886-06604eba4358 61 fields · synced May 18, 2026
- EUDAMED af395719-e453-4345-b8fc-5b0288bc1f8c 61 fields · synced May 18, 2026