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Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit
EUDAMEDClass IVD General (EU MDR)
Ref SC30107W-10T
Identity
- Trade Name
- Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit EUDAMED
- Device Name
- Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit EUDAMED
- Model / Reference
- SC30107W-10T EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-SC30107W-10TY4 EUDAMED
- Basic UDI-DI
- B-SC30107W-10TY4 EUDAMED
- EMDN Code
- W0105099099 VIROLOGY - RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit by Jiangsu Bioperfectus Technologies 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-SC30107W-10TY4 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Jiangsu Bioperfectus Technologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000014691
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 50694267-f6ab-45bc-a4f4-9febb8d6fb52 61 fields · synced Jun 18, 2026