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9 Diarrhea Bacteria Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)
EUDAMEDClass IVD General (EU MDR)
Ref S3283E-48Ref S3283E-24
Identity
- Device Name
- 9 Diarrhea Bacteria Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) EUDAMED
- Model / Reference
- S3283E-48 EUDAMEDS3283E-24 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792734906 EUDAMED06955792734890 EUDAMED
- Basic UDI-DI
- B-06955792734906 EUDAMEDB-06955792734890 EUDAMED
- EMDN Code
- W0105900102 REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France 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
9 Diarrhea Bacteria Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) 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-06955792734906 | 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 89133a32-d970-47bd-9be0-5f120e9078a8 61 fields · synced Jul 22, 2026
- EUDAMED 234024e7-be1e-4689-b2de-c1928a20341e 61 fields · synced May 16, 2026