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ONE STEP Dengue NS1 Ag Rapid Test (Colloidal Gold)
EUDAMEDClass IVD General (EU MDR)
Ref SUPG020025-1
Identity
- Trade Name
- ONE STEP Dengue NS1 Ag Rapid Test (Colloidal Gold) EUDAMED
- Device Name
- ONE STEP Dengue NS1 Ag Rapid Test (Colloidal Gold) EUDAMED
- Model / Reference
- SUPG020025-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974521001898 EUDAMED
- Basic UDI-DI
- B-06974521001898 EUDAMED
- EMDN Code
- W0105099007 DENGUE - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General 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
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
ONE STEP Dengue NS1 Ag Rapid Test (Colloidal Gold) 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-06974521001898 | 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 (1)
- EUDAMED 7c4bd882-ceea-4874-aa41-4ba5f2ce1600 61 fields · synced Jul 11, 2026