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Human Coronavirus 229E, NL63, OC43, HKU1, MERS, SARS Multiple Nucleic Acid Diag…
EUDAMEDClass IVD General (EU MDR)
Ref S3168E-48
Identity
- Trade Name
- Human Coronavirus 229E, NL63, OC43, HKU1, MERS, SARS Multiple Nucleic Acid Diagnostic Kit (Multiple Fluorescence PCR) EUDAMED
- Device Name
- Human Coronavirus 229E, NL63, OC43, HKU1, MERS, SARS Multiple Nucleic Acid Diagnostic Kit (Multiple Fluorescence PCR) EUDAMED
- Model / Reference
- S3168E-48 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792733688 EUDAMED
- Basic UDI-DI
- B-06955792733688 EUDAMED
- EMDN Code
- W0105040519 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 Coronavirus 229E, NL63, OC43, HKU1, MERS, SARS Multiple Nucleic Acid Diag… 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-06955792733688 | 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 (1)
- EUDAMED 6d01c358-bad5-45e9-b5b8-5202e4ead3b0 61 fields · synced Jun 18, 2026