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Dengue (NS1 Ag+IgG/IgM) DUO Rapid Test Kit
EUDAMEDClass IVD General (EU MDR)
Ref SC20301W-25TRef SC20301W-50T
Identity
- Trade Name
- Dengue (NS1 Ag+IgG/IgM) DUO Rapid Test Kit EUDAMED
- Device Name
- Dengue (NS1 Ag+IgG/IgM) DUO Rapid Test Kit EUDAMED
- Model / Reference
- SC20301W-25T EUDAMEDSC20301W-50T EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-SC20301W-25TWK EUDAMEDD-SC20301W-50TWK EUDAMED
- Basic UDI-DI
- B-SC20301W-25TWK EUDAMEDB-SC20301W-50TWK EUDAMED
- EMDN Code
- W0105099007 DENGUE - 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
Dengue (NS1 Ag+IgG/IgM) DUO 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-SC20301W-25TWK | 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 dd0b84e5-963c-4c47-8f0e-045c1a1f6fb4 61 fields · synced Jul 16, 2026
- EUDAMED d4d9b8de-5e88-4213-84d8-e9b248ec2fe6 61 fields · synced May 19, 2026