← Back to catalogue
SARS-CoV-2 & Influenza A+B & RSV & ADV Antigen Combo Test Kit (Colloidal Gold)
EUDAMEDClass C (EU MDR)
Ref CFRA1ST-15Model Cassette
Identity
- Trade Name
- SARS-CoV-2 & Influenza A+B & RSV & ADV Antigen Combo Test Kit (Colloidal Gold) EUDAMED
- Device Name
- SARS-CoV-2 & Influenza A+B & RSV & ADV Antigen Combo Test Kit (Colloidal Gold) EUDAMED
- Model / Reference
- Cassette EUDAMEDCFRA1ST-15 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952062774044 EUDAMED
- Basic UDI-DI
- 69520627J034LD EUDAMED
- Unit of Use DI
- 06952062712732 EUDAMED
- EMDN Code
- W0105099099 VIROLOGY - RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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
SARS-CoV-2 & Influenza A+B & RSV & ADV Antigen Combo Test Kit (Colloidal Gold) by Anhui Deepblue Medical Technology Co., Ltd — Class C — IVDR — listed in…
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 | 69520627J034LD | Class C | Active |
Is this your device? Claim it to add documentation and request validation.
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 5754a04e-9fb4-4e07-b6d2-0019e775171c 61 fields · synced Oct 10, 2026