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COVID-19 antigen Rapid Test Device(Colloidal Gold)
EUDAMEDClass IVD General (EU MDR)
Ref 3040101901Model COV-201（25pcs）Ref 3040103501Model COV-201（5pcs）
Identity
- Device Name
- COVID-19 antigen Rapid Test Device(Colloidal Gold) EUDAMED
- Model / Reference
- COV-201（25pcs） EUDAMED3040101901 EUDAMEDCOV-201（5pcs） EUDAMED3040103501 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-69717712000578B EUDAMEDD-69717712000407S EUDAMED
- Basic UDI-DI
- B-69717712000578B EUDAMEDB-69717712000407S EUDAMED
- EMDN Code
- W0105040619 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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 antigen Rapid Test Device(Colloidal Gold) by Hangzhou Lysun Biotechnology 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-69717712000578B | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Lysun Biotechnology Co., Ltd
- EUDAMED SRN
- CN-MF-000010254
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED e6218a8b-c8e1-4952-adc0-6e26d10c7bbd 61 fields · synced Oct 6, 2026
- EUDAMED f5de7dfa-c431-48ed-ae08-269cb3fb8e73 61 fields · synced May 18, 2026