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Detection Kit for 2019-nCoV - N
EUDAMEDClass IVD General (EU MDR)
Ref DA1170Model Large package, 48 tests/kitRef DA1171Model Large package, 96 tests/kit
Identity
- Device Name
- Detection Kit for 2019-nCoV (N/E/RDRP Gene) EUDAMED
- Model / Reference
- Large package, 48 tests/kit EUDAMEDDA1170 EUDAMEDLarge package, 96 tests/kit EUDAMEDDA1171 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06928103011706 EUDAMED06928103011713 EUDAMED
- Basic UDI-DI
- B-06928103011706 EUDAMEDB-06928103011713 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 - N by Daan Gene Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — 3 models — 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-06928103011706 | 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 (2)
- EUDAMED 8daacec1-85d4-4eab-b732-ad293ebf0028 61 fields · synced Jul 29, 2026
- EUDAMED 799de1a6-c1ad-4d08-9996-10a80f0d6621 61 fields · synced May 19, 2026