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Influenza A&B Rapid Test Kit
EUDAMEDClass IVD General (EU MDR)
Ref .SC10101W-20TModel SC10101W-20TRef SC10101W-25T
Identity
- Trade Name
- Influenza A&B Rapid Test Kit EUDAMED
- Device Name
- Influenza A&B Rapid Test Kit EUDAMED
- Model / Reference
- SC10101W-20T EUDAMED.SC10101W-20T EUDAMEDSC10101W-25T EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-SC10101W-20TTZ EUDAMEDD-SC10101W-25TUG EUDAMED
- Basic UDI-DI
- B-SC10101W-20TTZ EUDAMEDB-SC10101W-25TUG EUDAMED
- EMDN Code
- W0105099004 INFLUENZA A AND /OR B - RT & POC 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
Influenza A&B Rapid Test Kit by Jiangsu Bioperfectus Technologies Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-SC10101W-20TTZ | 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 (2)
- EUDAMED 0213cab8-d33e-4894-a127-9f968a29a36c 61 fields · synced Sep 18, 2026
- EUDAMED a6ead36f-d493-4136-9f5e-8f9f01870595 61 fields · synced May 18, 2026