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Detection Kit for 2019 Novel Coronavirus (2019-nCoV) RNA (PCR-Fluorescence Prob…
EUDAMEDClass IVD General (EU MDR)
Ref DA0931Model Large package, 48 tests/kitRef DA0933Model Large package, 480 tests/kitRef DA0934Model Large package, 960 tests/kitRef DA0932Model Large package, 96 tests/kit
Identity
- Device Name
- Detection Kit for 2019 Novel Coronavirus (2019-nCoV) RNA (PCR-Fluorescence Probing) EUDAMED
- Model / Reference
- Large package, 48 tests/kit EUDAMEDDA0931 EUDAMEDLarge package, 480 tests/kit EUDAMEDDA0933 EUDAMEDLarge package, 960 tests/kit EUDAMEDDA0934 EUDAMEDLarge package, 96 tests/kit EUDAMEDDA0932 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06928103009314 EUDAMED06928103009338 EUDAMED06928103009345 EUDAMED06928103009321 EUDAMED
- Basic UDI-DI
- B-06928103009314 EUDAMEDB-06928103009338 EUDAMEDB-06928103009345 EUDAMEDB-06928103009321 EUDAMED
- EMDN Code
- W0105040599 VIROLOGY - NA REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain 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
Detection Kit for 2019 Novel Coronavirus (2019-nCoV) RNA (PCR-Fluorescence Prob… by Daan Gene Co., Ltd. — 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-06928103009314 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Daan Gene Co., Ltd.
- EUDAMED SRN
- CN-MF-000025799
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (4)
- EUDAMED 1fc70fc9-aa29-44c2-be95-5e83f8b2bef0 61 fields · synced Oct 6, 2026
- EUDAMED e05c465d-7471-45a2-9a6c-b1781df7a970 61 fields · synced May 17, 2026
- EUDAMED 1ff23981-5786-458d-be89-54ef6a28408d 61 fields · synced May 17, 2026
- EUDAMED 6fd6e3b6-f5ca-47e8-8e9c-e126cd7ba012 61 fields · synced May 18, 2026