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COVID-19 Antigen Rapid Test Kit（Colloidal Gold） -for self-testing
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref 1 Test/Box
by Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd.
Identity
- Device Name
- COVID-19 Antigen Rapid Test Kit（Colloidal Gold） -for self-testing EUDAMED
- Model / Reference
- 1 Test/Box EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934822526018 EUDAMED
- Basic UDI-DI
- B-06934822526018 EUDAMED
- EMDN Code
- W0105099099 VIROLOGY - RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
COVID-19 Antigen Rapid Test Kit（Colloidal Gold） -for self-testing by Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd. — Class IVD devices for…
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-06934822526018 | Class IVD devices for self-testing | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000016839
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 4261b77d-cf8a-4881-a92b-f4bd9045d140 61 fields · synced Jun 18, 2026