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SARS-CoV2 & Influenza A/B Antigen Kit (Colloidal Gold)
EUDAMEDClass IVD General (EU MDR)
Ref CG125005Ref CG125025Ref CG125001
Identity
- Trade Name
- SARS-CoV2 & Influenza A/B Antigen Kit (Colloidal Gold) EUDAMED
- Device Name
- SARS-CoV2 & Influenza A/B Antigen Kit (Colloidal Gold) EUDAMED
- Model / Reference
- CG125005 EUDAMEDCG125025 EUDAMEDCG125001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971225930271 EUDAMED06971225937348 EUDAMED06971225936211 EUDAMED
- Basic UDI-DI
- B-06971225930271 EUDAMEDB-06971225937348 EUDAMEDB-06971225936211 EUDAMED
- EMDN Code
- W0105070304 INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy 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
SARS-CoV2 & Influenza A/B Antigen Kit (Colloidal Gold) by Goldsite Diagnostics Inc. — 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-06971225930271 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Goldsite Diagnostics Inc.
- EUDAMED SRN
- CN-MF-000001353
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (3)
- EUDAMED 210b9946-ac19-4b47-98a6-eb858a82fc48 61 fields · synced Jul 14, 2026
- EUDAMED 50a7fc8d-52b0-449f-a326-837e40988e9d 61 fields · synced May 17, 2026
- EUDAMED a2e86bf6-fd82-41f5-96dd-b202e7614c7a 61 fields · synced May 17, 2026