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Legionella pneumophila Nucleic Acid Diagnostic Kit (PCR Fluorescence Probing)
EUDAMEDClass IVD General (EU MDR)
Ref S3313E-48Ref S3313E-24-P
Identity
- Device Name
- Legionella pneumophila Nucleic Acid Diagnostic Kit (PCR Fluorescence Probing) EUDAMED
- Model / Reference
- S3313E-48 EUDAMEDS3313E-24-P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792731806 EUDAMED06955792731813 EUDAMED
- Basic UDI-DI
- B-06955792731806 EUDAMEDB-06955792731813 EUDAMED
- EMDN Code
- W0105010503 LEGIONELLA DETECTION BY NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France EUDAMEDPoland 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
Legionella pneumophila 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-06955792731806 | 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 f8db141a-d9cf-48d2-889d-4307d07ec12e 61 fields · synced Jul 10, 2026
- EUDAMED 12817142-2f86-49da-a2de-15869fe28aa5 61 fields · synced May 19, 2026