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Ureaplasma Urealyticum DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probin…
EUDAMEDClass IVD General (EU MDR)
Ref S3004E
Identity
- Trade Name
- Ureaplasma Urealyticum DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) EUDAMED
- Device Name
- Ureaplasma Urealyticum DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) EUDAMED
- Model / Reference
- S3004E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792730816 EUDAMED06955792730809 EUDAMED
- Basic UDI-DI
- B-06955792730816 EUDAMEDB-06955792730809 EUDAMED
- EMDN Code
- W0104080207 MYCOPLASMA / UREAPLASMA - (INCL. COMBINED ID-AST) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy EUDAMEDGermany 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
Ureaplasma Urealyticum DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probin… 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-06955792730816 | 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 (2)
- EUDAMED 382c756c-a43b-4ca1-be67-d7a7f503e30e 61 fields · synced Aug 4, 2026
- EUDAMED 13242a06-b509-4bac-84e8-9a050bc74dce 61 fields · synced May 17, 2026