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2019-nCoV Antigen Rapid Test (Immunochromatography Assay)
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref SUPL010005
Identity
- Trade Name
- 2019-nCoV Antigen Rapid Test (Immunochromatography Assay) EUDAMED
- Device Name
- 2019-nCoV Antigen Rapid Test (Immunochromatography Assay) EUDAMED
- Model / Reference
- SUPL010005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974521001706 EUDAMED
- Basic UDI-DI
- B-06974521001706 EUDAMED
- EMDN Code
- W0105099099 VIROLOGY - RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
2019-nCoV Antigen Rapid Test (Immunochromatography Assay) by Shenzhen Superbio Technology Co., Ltd. — Class IVD devices for self-testing — IVDD — listed in…
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-06974521001706 | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- Shenzhen Superbio Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000024149
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED 6346d1e7-cc29-436f-baf2-eddd61c60a51 61 fields · synced Jun 19, 2026