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Herpes Simplex Virus Type 2 DNA Fluorescence Diagnostic Kit (PCR-Fluorescence P…
EUDAMEDClass IVD General (EU MDR)
Ref S3002E
Identity
- Trade Name
- Herpes Simplex Virus Type 2 DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) EUDAMED
- Device Name
- Herpes Simplex Virus Type 2 DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) EUDAMED
- Model / Reference
- S3002E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792730762 EUDAMED06955792730779 EUDAMED
- Basic UDI-DI
- B-06955792730762 EUDAMEDB-06955792730779 EUDAMED
- EMDN Code
- W0105040311 HSV - NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Portugal 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
Herpes Simplex Virus Type 2 DNA Fluorescence Diagnostic Kit (PCR-Fluorescence P… 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-06955792730762 | 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 d30ce466-ab3f-4f3c-b00d-763957fd7171 61 fields · synced Jul 10, 2026
- EUDAMED 381624c0-1b89-40d3-b7a7-b4075388be9d 61 fields · synced May 16, 2026