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Dengue virus, Zika virus, and Chikungunya virus Nucleic Acid Diagnostic Kit (PC…
EUDAMEDClass IVD General (EU MDR)
Ref S3333E-12-SRef S3332E-24Ref S3333E-48Ref S3333E-24
Identity
- Device Name
- Dengue virus, Zika virus, and Chikungunya virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) EUDAMEDChikungunya virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) EUDAMED
- Model / Reference
- S3333E-12-S EUDAMEDS3332E-24 EUDAMEDS3333E-48 EUDAMEDS3333E-24 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792714632 EUDAMED06955792732148 EUDAMED06955792732322 EUDAMED06955792732315 EUDAMED
- Basic UDI-DI
- B-06955792714632 EUDAMEDB-06955792732148 EUDAMEDB-06955792732322 EUDAMEDB-06955792732315 EUDAMED
- EMDN Code
- W0105070506 TROPICAL FEVER - MULTIPLEX NA REAGENTS EUDAMEDW0105040525 CHIKUNGUNYA VIRUS - 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
Dengue virus, Zika virus, and Chikungunya virus Nucleic Acid Diagnostic Kit (PC… 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-06955792714632 | 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 (4)
- EUDAMED 9c1d8e8f-7b48-4760-8eb5-27c0030530a3 61 fields · synced Oct 6, 2026
- EUDAMED 9e8625bb-55ba-40cc-8a5e-4f89acabbd06 61 fields · synced May 17, 2026
- EUDAMED 650157fe-b853-44a0-99c0-286721e2bff0 61 fields · synced May 18, 2026
- EUDAMED dbd406d7-d6df-478d-afcd-3906585b02be 61 fields · synced May 18, 2026