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Mycobacterium tuberculosis (MTB) Nucleic Acid Diagnostic Kit (PCR-Fluorescence …
EUDAMEDClass IVD General (EU MDR)
Ref S3274E-24Ref S3274E-48
Identity
- Device Name
- Mycobacterium tuberculosis (MTB) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) EUDAMED
- Model / Reference
- S3274E-24 EUDAMEDS3274E-48 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792731875 EUDAMED06955792731882 EUDAMED
- Basic UDI-DI
- B-06955792731875 EUDAMEDB-06955792731882 EUDAMED
- EMDN Code
- W0105010703 MYCOBACTERIAL DETECTION BY NA REAGENTS 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
Mycobacterium tuberculosis (MTB) Nucleic Acid Diagnostic Kit (PCR-Fluorescence … 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-06955792731875 | 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 b0ba0ace-94f4-461f-a6a6-5d50023be7e5 61 fields · synced Jul 17, 2026
- EUDAMED ffe41747-787c-432e-b3b2-e3c1952b753e 61 fields · synced May 18, 2026