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Hepatitis B Virus DNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescenc…
EUDAMEDClass IVD Annex II List A (EU MDR)
Ref S3118E-48
Identity
- Trade Name
- Hepatitis B Virus DNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) EUDAMED
- Device Name
- Hepatitis B Virus DNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) EUDAMED
- Model / Reference
- S3118E-48 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792731134 EUDAMED
- Basic UDI-DI
- B-06955792731134 EUDAMED
- EMDN Code
- W0105020216 HEPATITIS B VIRUS - NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD Annex II List A 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
Hepatitis B Virus DNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescenc… by Sansure Biotech Inc. — Class IVD Annex II List A — 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-06955792731134 | Class IVD Annex II List A | Active |
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Manufacturer
- Manufacturer
- Sansure Biotech Inc.
- EUDAMED SRN
- CN-MF-000011392
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 0dfebd26-b3ad-44ef-a527-2e5fe445cf8b 61 fields · synced Jul 11, 2026