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Novel Coronavirus(2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Prob…
EUDAMEDClass IVD General (EU MDR)
Ref S3102ERef S3106ERef S3107E-24
Identity
- Trade Name
- Novel Coronavirus(2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) EUDAMEDNovel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) EUDAMED
- Device Name
- Novel Coronavirus(2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) EUDAMEDNovel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) EUDAMED
- Model / Reference
- S3102E EUDAMEDS3106E EUDAMEDS3107E-24 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792731158 EUDAMED06955792733411 EUDAMED06955792733459 EUDAMED06955792731165 EUDAMED
- Basic UDI-DI
- B-06955792731158 EUDAMEDB-06955792733411 EUDAMEDB-06955792733459 EUDAMEDB-06955792731165 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
Novel Coronavirus(2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Prob… 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-06955792731158 | 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 3732d209-54fb-41a7-ac81-e4c15a2c0374 61 fields · synced Oct 5, 2026
- EUDAMED 756e753f-2ea7-4c06-926a-4ec0e44aa434 61 fields · synced May 17, 2026
- EUDAMED 37e5db02-65b7-404d-99c6-9f90134e8693 61 fields · synced May 18, 2026
- EUDAMED c869e091-49c0-4a0d-85f7-a8ff79a6c55f 61 fields · synced May 19, 2026