← Back to catalogue
Astrovirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)
EUDAMEDClass IVD General (EU MDR)
Ref S3228E-24Ref S3228E-48
Identity
- Device Name
- Astrovirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) EUDAMED
- Model / Reference
- S3228E-24 EUDAMEDS3228E-48 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792735354 EUDAMED06955792735361 EUDAMED
- Basic UDI-DI
- B-06955792735354 EUDAMEDB-06955792735361 EUDAMED
- EMDN Code
- W0105040501 ADENOVIRUS - 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
Astrovirus Nucleic Acid 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-06955792735354 | Class IVD General | 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 (2)
- EUDAMED 5f055b28-97d9-458b-80dd-5e75bfcce0f8 61 fields · synced Jul 17, 2026
- EUDAMED e1d215dd-7733-4ed7-b4d3-1051a4b6745c 61 fields · synced May 16, 2026