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Neisseria Meningitidis Serogroup A, B, and C nucleic acid Diagnostic Kit（PCR-Fl…
EUDAMEDClass IVD General (EU MDR)
Ref S3263E-24Ref S3263E-48
Identity
- Trade Name
- Neisseria Meningitidis Serogroup A, B, and C nucleic acid Diagnostic Kit（PCR-Fluorescence Probing) EUDAMED
- Device Name
- Neisseria Meningitidis Serogroup A, B, and C nucleic acid Diagnostic Kit（PCR-Fluorescence Probing) EUDAMED
- Model / Reference
- S3263E-24 EUDAMEDS3263E-48 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792734289 EUDAMED06955792734296 EUDAMED
- Basic UDI-DI
- B-06955792734289 EUDAMEDB-06955792734296 EUDAMED
- EMDN Code
- W0105011611 NEISSERIA MENINGITIDIS - 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
Neisseria Meningitidis Serogroup A, B, and C nucleic acid Diagnostic Kit（PCR-Fl… 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-06955792734289 | 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 75ad7525-06d9-4c11-9a7b-08d8ca5d3c8d 61 fields · synced Oct 7, 2026
- EUDAMED 801d3632-e3d4-46b9-9ee3-e6e416fa3ff6 61 fields · synced May 18, 2026