← Back to catalogue
Epstein-Barr virus DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)
EUDAMEDClass C (EU MDR)
Ref S3213E-48
Identity
- Device Name
- Epstein-Barr virus DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) EUDAMED
- Model / Reference
- S3213E-48 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792701663 EUDAMED
- Basic UDI-DI
- 69557927S3213E000001PC EUDAMED
- Direct Marketing DI
- 06955792701663 EUDAMED
- EMDN Code
- W0105040403 EBV - NA REAGENTS EUDAMED
Classification
- Device Class
- Class C 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
New Device
Yes
EUDAMED
Epstein-Barr virus DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) by Sansure Biotech Inc. — Class C — IVDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 69557927S3213E000001PC | Class C | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sansure Biotech Inc.
- EUDAMED SRN
- CN-MF-000011392
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 1cce77f9-d347-4323-a49d-692a8e73c4c9 61 fields · synced Jul 30, 2026