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Detection Kit for 2019-nCoV Nucleic Acid (Thermostatic Amplification-LFIA)
EUDAMEDClass IVD General (EU MDR)
Ref DA1391Model 25 tests/kit
Identity
- Device Name
- Detection Kit for 2019-nCoV Nucleic Acid (Thermostatic Amplification-LFIA) EUDAMED
- Model / Reference
- 25 tests/kit EUDAMEDDA1391 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06928103013915 EUDAMED
- Basic UDI-DI
- B-06928103013915 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
Yes
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
Detection Kit for 2019-nCoV Nucleic Acid (Thermostatic Amplification-LFIA) 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-06928103013915 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Daan Gene Co., Ltd.
- EUDAMED SRN
- CN-MF-000025799
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED cb9599b9-56dd-44a6-91b5-24f69d3e88d2 61 fields · synced Jun 18, 2026