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Six Respiratory Pathogens Multiplex Nucleic Acid Diagnostic Kit (Multiplex PCR-…
EUDAMEDClass IVD General (EU MDR)
Ref S3310E-12-SRef S3163E-48Ref S3310E-24
Identity
- Trade Name
- Six Respiratory Pathogens Multiplex Nucleic Acid Diagnostic Kit (Multiplex PCR-Fluorescence Probing) EUDAMED
- Device Name
- Six Respiratory Pathogens Multiplex Nucleic Acid Diagnostic Kit (Multiplex PCR-Fluorescence Probing) EUDAMEDMultiple Respiratory Pathogens Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) EUDAMED
- Model / Reference
- S3310E-12-S EUDAMEDS3163E-48 EUDAMEDS3310E-24 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792714656 EUDAMED06955792732735 EUDAMED06955792701069 EUDAMED
- Basic UDI-DI
- B-06955792714656 EUDAMEDB-06955792732735 EUDAMED69557927S3310E000001NG EUDAMED
- EMDN Code
- W0105070201 GRAM+ - GRAM- - FUNGI - MULTIPLEX NA REAGENTS EUDAMEDW0105070503 RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass C 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
New Device
No
EUDAMED
Six Respiratory Pathogens Multiplex Nucleic Acid Diagnostic Kit (Multiplex PCR-… by Sansure Biotech Inc. — Class IVD General — IVDR, IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06955792714656 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06955792714656 | 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 3ec509db-a87d-4026-8c87-1ea4d9951b33 61 fields · synced Jul 29, 2026
- EUDAMED be2142b1-e49e-400f-aa56-f0be29a43ac9 61 fields · synced May 17, 2026
- EUDAMED 0c9c2456-95cc-4a07-8378-6f883e9ba725 61 fields · synced May 18, 2026