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COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold)
EUDAMEDClass IVD General (EU MDR)
Ref SL030101
Identity
- Trade Name
- COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold) EUDAMED
- Device Name
- COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold) EUDAMED
- Model / Reference
- SL030101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952062772118 EUDAMED
- Basic UDI-DI
- B-06952062772118 EUDAMED
- EMDN Code
- W0105099099 VIROLOGY - RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold) by Anhui Deepblue Medical Technology 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-06952062772118 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Anhui Deepblue Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000018785
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED 61ff710a-4657-4c87-90ef-0daed57d9589 61 fields · synced Oct 7, 2026