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Bordetella Pertussis DNA Diagnostic Kit (PCR-Fluorescence Probing)
EUDAMEDClass IVD General (EU MDR)
Ref S3055E
Identity
- Trade Name
- Bordetella Pertussis DNA Diagnostic Kit (PCR-Fluorescence Probing) EUDAMED
- Device Name
- Bordetella Pertussis DNA Diagnostic Kit (PCR-Fluorescence Probing) EUDAMED
- Model / Reference
- S3055E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792731622 EUDAMED06955792731615 EUDAMED
- Basic UDI-DI
- B-06955792731622 EUDAMEDB-06955792731615 EUDAMED
- EMDN Code
- W0105011607 BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Poland EUDAMEDItaly 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
Bordetella Pertussis DNA 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-06955792731622 | 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 09b84eef-2223-49a3-85a1-8c75807ab523 61 fields · synced Jul 15, 2026
- EUDAMED a12c71f7-f436-4db5-b2c7-39db4a0d4ab3 61 fields · synced May 19, 2026