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2019-Novel Coronavirus Mutants Test Kit (Fluorescent Probe-based real-time PCR …
EUDAMEDClass IVD General (EU MDR)
Ref R401T005B0C2
Identity
- Device Name
- 2019-Novel Coronavirus Mutants Test Kit (Fluorescent Probe-based real-time PCR assay) EUDAMED
- Model / Reference
- R401T005B0C2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970895476225 EUDAMED
- Basic UDI-DI
- B-06970895476225 EUDAMED
- EMDN Code
- W0105041106 CORONAVIRUS - NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
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
2019-Novel Coronavirus Mutants Test Kit (Fluorescent Probe-based real-time PCR … by Jiangsu Mole Bioscience Co., LTD. — Class IVD General — IVDD — listed in…
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-06970895476225 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Jiangsu Mole Bioscience Co., LTD.
- EUDAMED SRN
- CN-MF-000001539
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 2a395b4a-5138-4a6a-8ef4-0eb37a2a2475 61 fields · synced Jun 19, 2026