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InfluenzaA+B&COVID-19 (SARS-CoV-2)Antigen Test Kit(Colloidal Gold)
EUDAMEDClass C (EU MDR)
Ref COVAg+FluAB1NST-XModel Cassette
Identity
- Trade Name
- InfluenzaA+B&COVID-19 (SARS-CoV-2)Antigen Test Kit(Colloidal Gold) EUDAMED
- Device Name
- InfluenzaA+B&COVID-19 (SARS-CoV-2)Antigen Test Kit（Colloidal Gold） EUDAMED
- Model / Reference
- Cassette EUDAMEDCOVAg+FluAB1NST-X EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952062710707 EUDAMED
- Basic UDI-DI
- 69520627J017LD EUDAMED
- EMDN Code
- W0105099099 VIROLOGY - RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
InfluenzaA+B&COVID-19 (SARS-CoV-2)Antigen Test Kit(Colloidal Gold) by Anhui Deepblue Medical Technology Co., Ltd — Class C — IVDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 69520627J017LD | Class C | Active |
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Manufacturer
- Manufacturer
- Anhui Deepblue Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000018785
- Authorised Representative
- Mega Eurostar Sp. z o.o. PL-AR-000042730
Sources (1)
- EUDAMED 11acc69d-2707-4e80-a7bc-a2249c438a0c 61 fields · synced Oct 6, 2026