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ONE STEP Malaria (P.F) Rapid Test (Colloidal Gold)
EUDAMEDClass IVD General (EU MDR)
Ref SUPG016025Ref SUPG017025-1Ref ITP11003-TC40Model ITP11003
Identity
- Trade Name
- ONE STEP Malaria (P.F) Rapid Test (Colloidal Gold) EUDAMEDONE STEP Malaria P.F/P. V Tri-line Rapid Test (Colloidal Gold) EUDAMEDONE STEP Malaria(p.f/p.v) Tri-line Test EUDAMED
- Device Name
- ONE STEP Malaria (P.F) Rapid Test (Colloidal Gold) EUDAMEDONE STEP Malaria P.F/P. V Tri-line Rapid Test (Colloidal Gold) EUDAMEDONE STEP Malaria(p.f/p.v) Tri-line Test EUDAMED
- Model / Reference
- SUPG016025 EUDAMEDSUPG017025-1 EUDAMEDITP11003 EUDAMEDITP11003-TC40 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974521001904 EUDAMED06974521001935 EUDAMED06936155803651 EUDAMED
- Basic UDI-DI
- B-06974521001904 EUDAMEDB-06974521001935 EUDAMEDB-06936155803651 EUDAMED
- EMDN Code
- W0105099099 VIROLOGY - RT & POC - OTHER EUDAMEDW0105090401 PLASMODIUM (MALARIA) - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Ireland EUDAMEDBelgium 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 Malaria (P.F) 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-06974521001904 | 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 (3)
- EUDAMED f19b3e83-49b1-4a99-b9e5-ad5762efebec 61 fields · synced Jul 26, 2026
- EUDAMED 081f69f7-c577-4e3f-ba96-02188e990934 61 fields · synced May 18, 2026
- EUDAMED 8c80816a-12ce-4c5b-b2ec-39a223c98dd4 61 fields · synced Jul 15, 2026