← Back to catalogue
Detection Kit for 2019-nCoV (PCR-Fluorescence)
EUDAMEDClass IVD General (EU MDR)
Ref DA0997Model Large package, 960 tests/kit
Identity
- Device Name
- Detection Kit for 2019-nCoV (PCR-Fluorescence) EUDAMED
- Model / Reference
- Large package, 960 tests/kit EUDAMEDDA0997 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06928103009970 EUDAMED
- Basic UDI-DI
- B-06928103009970 EUDAMED
- EMDN Code
- W0105040599 VIROLOGY - NA REAGENTS - OTHER 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
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-06928103009970 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Daan Gene Co., Ltd.
- EUDAMED SRN
- CN-MF-000025799
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 6ab52961-3e91-4b70-903d-a7b2277ad0f2 61 fields · synced Jun 18, 2026