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Detection Kit for 2019-nCoV Nucleic Acid (RT-LAMP)
EUDAMEDClass IVD General (EU MDR)
Ref DA1400Model 1 tests/kitRef DA1401Model 25 tests/kit
Identity
- Device Name
- Detection Kit for 2019-nCoV Nucleic Acid (RT-LAMP) EUDAMED
- Model / Reference
- 1 tests/kit EUDAMEDDA1400 EUDAMED25 tests/kit EUDAMEDDA1401 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06928103014004 EUDAMED06928103014011 EUDAMED
- Basic UDI-DI
- B-06928103014004 EUDAMEDB-06928103014011 EUDAMED
- EMDN Code
- W0105040599 VIROLOGY - NA REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMEDFrance 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
Detection Kit for 2019-nCoV Nucleic Acid (RT-LAMP) 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-06928103014004 | 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 (2)
- EUDAMED 45a3b28a-49c9-44a8-a291-17191e404a4f 61 fields · synced Jul 12, 2026
- EUDAMED f9fc2fdb-e97a-4bd9-ae47-6e9ca39f74d3 61 fields · synced May 17, 2026