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2019-nCoV Antigen Rapid Test (Immunochromatography Assay)
EUDAMEDClass IVD General (EU MDR)
Ref SUPL010001Ref SUPL010003Ref SUPL010005Ref SUPL010025
Identity
- Trade Name
- 2019-nCoV Antigen Rapid Test (Immunochromatography Assay) EUDAMED
- Device Name
- 2019-nCoV Antigen Rapid Test (Immunochromatography Assay) EUDAMED
- Model / Reference
- SUPL010001 EUDAMEDSUPL010003 EUDAMEDSUPL010005 EUDAMEDSUPL010025 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974521001713 EUDAMED06974521001690 EUDAMED06974521001720 EUDAMED06974521001737 EUDAMED06974521001744 EUDAMED06974521001683 EUDAMED
- Basic UDI-DI
- B-06974521001713 EUDAMEDB-06974521001690 EUDAMEDB-06974521001720 EUDAMEDB-06974521001737 EUDAMEDB-06974521001744 EUDAMEDB-06974521001683 EUDAMED
- EMDN Code
- W0105099099 VIROLOGY - RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass 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
No
EUDAMEDEUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMEDEUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
2019-nCoV Antigen Rapid Test (Immunochromatography Assay) by Shenzhen Superbio Technology 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-06974521001713 | Class IVD General | 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 (6)
- EUDAMED cf881004-d98f-4635-99b9-fb79f02958b0 61 fields · synced Aug 3, 2026
- EUDAMED 1c6d52f5-0e72-44ae-a34a-c27242f8af76 61 fields · synced May 17, 2026
- EUDAMED 2869f14d-3fb7-4d6d-9ee8-a6a5958792c9 61 fields · synced May 17, 2026
- EUDAMED 0a91966c-533b-451f-8d16-b146f89c415b 61 fields · synced May 17, 2026
- EUDAMED cd95faf1-4be7-4726-a825-a957df6bec7a 61 fields · synced May 18, 2026
- EUDAMED 95589bf6-bf30-4f9c-9b70-0384790b6225 61 fields · synced May 19, 2026