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Human Parvovirus B19 DNA Diagnostic Kit (PCR-Fluorescence Probing)
EUDAMEDClass IVD General (EU MDR)
Ref S3214E-24Ref S3214E-48
Identity
- Trade Name
- Human Parvovirus B19 DNA Diagnostic Kit (PCR-Fluorescence Probing) EUDAMED
- Device Name
- Human Parvovirus B19 DNA Diagnostic Kit (PCR-Fluorescence Probing) EUDAMED
- Model / Reference
- S3214E-24 EUDAMEDS3214E-48 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792732704 EUDAMED06955792732711 EUDAMED
- Basic UDI-DI
- B-06955792732704 EUDAMEDB-06955792732711 EUDAMED
- EMDN Code
- W0105900102 REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS 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
Human Parvovirus B19 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-06955792732704 | 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 0226c857-61ec-4468-97a0-91d35b2c5ecc 61 fields · synced Jul 16, 2026
- EUDAMED 1a0d1da8-3874-45b7-9222-862f45147f81 61 fields · synced May 18, 2026