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Rapid SARS-CoV-2 Antigen Test Card
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref 1N40C5-2Model 1N40C5-2 (1 Test/Kit)
Identity
- Trade Name
- Rapid SARS-CoV-2 Antigen Test Card EUDAMED
- Device Name
- Rapid SARS-CoV-2 Antigen Test Card EUDAMED
- Model / Reference
- 1N40C5-2 (1 Test/Kit) EUDAMED1N40C5-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06921963712257 EUDAMED
- Basic UDI-DI
- B-06921963712257 EUDAMED
- EMDN Code
- W0105040619 EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Rapid SARS-CoV-2 Antigen Test Card by Xiamen Boson Biotech Co., Ltd. — Class IVD devices for self-testing — 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-06921963712257 | Class IVD devices for self-testing | 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 (1)
- EUDAMED a73100ad-b894-4c88-bf33-2d7db73aa4e5 61 fields · synced May 29, 2026