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Detection Kit for Zika Virus RNA (PCR-Fluorescence Probing)
EUDAMEDClass IVD General (EU MDR)
Ref DA0711Model Large Package, 48 tests/kitRef DA0710Model Large Package, 24 tests/kit
Identity
- Device Name
- Detection Kit for Zika Virus RNA (PCR-Fluorescence Probing) EUDAMED
- Model / Reference
- Large Package, 48 tests/kit EUDAMEDDA0711 EUDAMEDLarge Package, 24 tests/kit EUDAMEDDA0710 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06928103007112 EUDAMED06928103007105 EUDAMED
- Basic UDI-DI
- B-06928103007112 EUDAMEDB-06928103007105 EUDAMED
- EMDN Code
- W0105040531 ZIKA VIRUS - NA REAGENTS 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 Zika Virus RNA (PCR-Fluorescence Probing) 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-06928103007112 | 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 b6e35c6f-82e5-4971-924a-06f6e2c13ccd 61 fields · synced Jul 31, 2026
- EUDAMED 3c50de12-2963-4761-8f49-ec5d1ca2552e 61 fields · synced May 18, 2026