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Rapid SARS-CoV-2/Influenza A+B Antigen Duo Test Card
EUDAMEDClass IVD General (EU MDR)
Ref 1N41C5-27Ref 1N41C5-25
Identity
- Trade Name
- Rapid SARS-CoV-2/Influenza A+B Antigen Duo Test Card EUDAMED
- Device Name
- Rapid SARS-CoV-2/Influenza A+B Antigen Duo Test Card EUDAMED
- Model / Reference
- 1N41C5-27 EUDAMED1N41C5-25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06921963715357 EUDAMED06921963715913 EUDAMED
- Basic UDI-DI
- B-06921963715357 EUDAMEDB-06921963715913 EUDAMED
- EMDN Code
- W0105090601 CORONAVIRUS / INFLUENZA - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Greece 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
Rapid SARS-CoV-2/Influenza A+B Antigen Duo Test Card by Xiamen Boson Biotech 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-06921963715357 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Xiamen Boson Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000001096
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 044683aa-7994-4190-b8cb-2be83068c825 61 fields · synced Jul 19, 2026
- EUDAMED 91e5e636-1540-446d-ad63-bdd5c0ed1739 61 fields · synced May 16, 2026