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ONE STEP Dengue IgG/IgM - NS1 Combo Test (Colloidal Gold)
EUDAMEDClass IVD General (EU MDR)
Ref SUPG021025Ref SUPG021025-1
Identity
- Trade Name
- ONE STEP Dengue IgG/IgM - NS1 Combo Test (Colloidal Gold) EUDAMED
- Device Name
- ONE STEP Dengue IgG/IgM - NS1 Combo Test (Colloidal Gold) EUDAMED
- Model / Reference
- SUPG021025 EUDAMEDSUPG021025-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974521001867 EUDAMED06974521001874 EUDAMED
- Basic UDI-DI
- B-06974521001867 EUDAMEDB-06974521001874 EUDAMED
- EMDN Code
- W0105040611 DENGUE VIRUS 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 IgG/IgM - NS1 Combo 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-06974521001867 | 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 (2)
- EUDAMED 1f3ba29b-37f2-434d-9359-992f4a065c87 61 fields · synced Jul 14, 2026
- EUDAMED 40617665-db57-4414-9314-e0a6ea68b3c8 61 fields · synced May 17, 2026