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Mycobacterium tuberculosis DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Pr…
EUDAMEDClass C (EU MDR)
Ref S3354E-48Ref S3018E
Identity
- Trade Name
- Mycobacterium Tuberculosis DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) EUDAMED
- Device Name
- Mycobacterium tuberculosis DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) EUDAMED
- Model / Reference
- S3354E-48 EUDAMEDS3018E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792743700 EUDAMED06955792730977 EUDAMED
- Basic UDI-DI
- 69557927S3354E000001TQ EUDAMEDB-06955792730977 EUDAMED
- EMDN Code
- W0105010703 MYCOBACTERIAL DETECTION BY NA REAGENTS EUDAMED
Classification
- Device Class
- Class C EUDAMEDClass IVD General EUDAMED
- Market of Registration
- France EUDAMEDGreece 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
Mycobacterium tuberculosis DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Pr… by Sansure Biotech Inc. — Class C — IVDD, IVDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 69557927S3354E000001TQ | Class C | Active |
| EUDAMED | European Union | CE/IVDR | 69557927S3354E000001TQ | Class C | 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 8738ecbf-ba0a-41c5-b7d1-cca24fbdf3ff 61 fields · synced Jul 12, 2026
- EUDAMED a06dfbd1-461b-4003-a7f4-50276821526b 61 fields · synced May 19, 2026