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Detection Kit for 2019-nCoV (PCR-Fluorescence)
EUDAMEDClass IVD General (EU MDR)
Ref DA0993Model Single tube, 24 tests/kitRef DA1072Model Large package, 96 tests/kitRef DA1075Model Single tube, 96 tests/kitRef DA0995Ref DA0992Ref DA0991Model Large package, 48 tests/kitRef DA1077Model Large package, 960 tests/kitRef DA0996Model Large package, 480 tests/kitRef DA1076Ref DA1071
Identity
- Device Name
- Detection Kit for 2019-nCoV (PCR-Fluorescence) EUDAMED
- Model / Reference
- Single tube, 24 tests/kit EUDAMEDDA0993 EUDAMEDLarge package, 96 tests/kit EUDAMEDDA1072 EUDAMEDSingle tube, 96 tests/kit EUDAMEDDA1075 EUDAMEDDA0995 EUDAMEDDA0992 EUDAMEDLarge package, 48 tests/kit EUDAMEDDA0991 EUDAMEDLarge package, 960 tests/kit EUDAMEDDA1077 EUDAMEDLarge package, 480 tests/kit EUDAMEDDA0996 EUDAMEDDA1076 EUDAMEDDA1071 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06928103009932 EUDAMED06928103010723 EUDAMED06928103010754 EUDAMED06928103009956 EUDAMED06928103009925 EUDAMED06928103009918 EUDAMED06928103010778 EUDAMED06928103009963 EUDAMED06928103010761 EUDAMED06928103010716 EUDAMED
- Basic UDI-DI
- B-06928103009932 EUDAMEDB-06928103010723 EUDAMEDB-06928103010754 EUDAMEDB-06928103009956 EUDAMEDB-06928103009925 EUDAMEDB-06928103009918 EUDAMEDB-06928103010778 EUDAMEDB-06928103009963 EUDAMEDB-06928103010761 EUDAMEDB-06928103010716 EUDAMED
- EMDN Code
- W0105040599 VIROLOGY - NA REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France EUDAMEDGermany 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-nCoV (PCR-Fluorescence) by Daan Gene Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06928103009932 | 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 (10)
- EUDAMED a0b12f4e-4bcd-4b1d-bb64-7ed2429b30fa 61 fields · synced Aug 2, 2026
- EUDAMED 8a8a841b-68ea-4995-907b-4eb270e506cf 61 fields · synced May 16, 2026
- EUDAMED 885558a9-7ed1-4aee-a1ed-b7e222f4bc78 61 fields · synced May 16, 2026
- EUDAMED 15ed30b2-53e3-4419-99c0-5e8ab4394dd0 61 fields · synced May 17, 2026
- EUDAMED d6c3e104-532b-455f-84c9-afcd58de93bc 61 fields · synced May 17, 2026
- EUDAMED 72adfd84-a2fb-4616-ad80-420dbe6dec57 61 fields · synced May 17, 2026
- EUDAMED 4aeaed41-0614-4dbe-8c33-396f5faf97f7 61 fields · synced May 17, 2026
- EUDAMED 7c5640a4-aec2-4e0b-898b-c2bdf3348491 61 fields · synced May 17, 2026
- EUDAMED 470a9889-d8f6-4b02-bb44-f2385e23b8d2 61 fields · synced May 18, 2026
- EUDAMED 9351caec-f5cd-48bb-870f-01ac87fe518e 61 fields · synced May 19, 2026