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Shigella/Salmonella/Escherichia coli O157 Nucleic Acid Diagnostic Kit (PCR-Fluo…
EUDAMEDClass IVD General (EU MDR)
Ref S3229E-24Ref S3229E-48
Identity
- Device Name
- Shigella/Salmonella/Escherichia coli O157 Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) EUDAMED
- Model / Reference
- S3229E-24 EUDAMEDS3229E-48 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792734364 EUDAMED06955792734371 EUDAMED
- Basic UDI-DI
- B-06955792734364 EUDAMEDB-06955792734371 EUDAMED
- EMDN Code
- W0105011699 BACTERIOLOGY - NA REAGENTS - OTHER 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
Shigella/Salmonella/Escherichia coli O157 Nucleic Acid Diagnostic Kit (PCR-Fluo… 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-06955792734364 | 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 4e30b255-a13f-4a9a-93e6-e7b6a322b21e 61 fields · synced Jul 27, 2026
- EUDAMED 8a82225f-04a9-4dd4-a037-664e3eca7146 61 fields · synced May 18, 2026