← Back to catalogue
Dengue NS1 Antigen Rapid Test Cassette (Colloidal Gold)
EUDAMEDClass IVD General (EU MDR)
Ref GKPD035Model 1T/BOX,10T/BOX,20T/BOX,25T/BOX,40T/BOX,50T/BOX
Identity
- Trade Name
- Dengue NS1 Antigen Rapid Test Cassette (Colloidal Gold) EUDAMED
- Device Name
- Dengue NS1 Antigen Rapid Test Cassette (Colloidal Gold) EUDAMED
- Model / Reference
- 1T/BOX,10T/BOX,20T/BOX,25T/BOX,40T/BOX,50T/BOX EUDAMEDGKPD035 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977698401911 EUDAMED
- Basic UDI-DI
- B-06977698401911 EUDAMED
- EMDN Code
- W0105040611 DENGUE VIRUS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
Dengue NS1 Antigen Rapid Test Cassette (Colloidal Gold) by Dezhou Guoke Medical 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-06977698401911 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dezhou Guoke Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000044128
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED ff55a07c-75ca-478a-ac8f-c4fd021ab442 61 fields · synced Aug 1, 2026