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COVID-19 Nucleic Acid Detection Kit(Fluorescence PCR)
EUDAMEDClass IVD General (EU MDR)
Ref 100 Tests/KitRef 50 Tests/Kit
Identity
- Device Name
- COVID-19 Nucleic Acid Detection Kit(Fluorescence PCR) EUDAMED
- Model / Reference
- 100 Tests/Kit EUDAMED50 Tests/Kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-201059001020544Y EUDAMEDD-101059001020433G EUDAMED
- Basic UDI-DI
- B-201059001020544Y EUDAMEDB-101059001020433G EUDAMED
- EMDN Code
- W0105900102 REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands 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
COVID-19 Nucleic Acid Detection Kit(Fluorescence PCR) by Beijing Healthgene Laboratory 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-201059001020544Y | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Beijing Healthgene Laboratory Co., Ltd
- EUDAMED SRN
- CN-MF-000032465
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 7db009a1-d720-4b0e-9fc8-67a8c567e0e3 61 fields · synced Aug 1, 2026
- EUDAMED 310395cd-a046-429d-b6fa-406aadc1ccb1 61 fields · synced May 18, 2026