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2019-Novel Coronavirus Mutants Test Kit (Fluorescent Probe-Based Real-Time PCR …
EUDAMEDClass IVD General (EU MDR)
Ref R401T013B0C2Ref R401T108B0C2 Ref R401T001B0C2 Ref R401T008B0C2 Ref R401T010B0C2Ref R401T015B0C2Ref R401T011B0C2
Identity
- Device Name
- 2019-Novel Coronavirus Mutants Test Kit (Fluorescent Probe-Based Real-Time PCR Assay) EUDAMED
- Model / Reference
- R401T013B0C2 EUDAMEDR401T108B0C2 EUDAMEDR401T001B0C2 EUDAMEDR401T008B0C2 EUDAMEDR401T010B0C2 EUDAMEDR401T015B0C2 EUDAMEDR401T011B0C2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970895476140 EUDAMED06970895476218 EUDAMED06970895476188 EUDAMED06970895476201 EUDAMED06970895476195 EUDAMED06970895476232 EUDAMED06970895476164 EUDAMED
- Basic UDI-DI
- B-06970895476140 EUDAMEDB-06970895476218 EUDAMEDB-06970895476188 EUDAMEDB-06970895476201 EUDAMEDB-06970895476195 EUDAMEDB-06970895476232 EUDAMEDB-06970895476164 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-06970895476140 | 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 (7)
- EUDAMED f2a0b8e6-e798-440e-96c7-7d7ea2e6afa0 61 fields · synced Sep 18, 2026
- EUDAMED 9525a2aa-3529-49ae-b42f-4823ebb5a588 61 fields · synced May 17, 2026
- EUDAMED 3bc731c4-b542-40e1-b812-048a9aa67a0c 61 fields · synced May 17, 2026
- EUDAMED f6f42f79-4ab4-4ccf-b3ce-678580063a66 61 fields · synced May 17, 2026
- EUDAMED efd35564-f7aa-4432-b38c-2018bc2d9f07 61 fields · synced May 17, 2026
- EUDAMED 61d4f5f9-28a5-4ff0-84d4-e6797aeec3f5 61 fields · synced May 17, 2026
- EUDAMED fe387d77-2659-44de-a25c-441b43c329d5 61 fields · synced May 19, 2026