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Enterovirus 71 (EV71) and Coxsackievirus A16 (CA16) Antigen Combo Rapid Test Kit
EUDAMEDClass IVD General (EU MDR)
Ref GKPD128
Identity
- Trade Name
- Enterovirus 71 (EV71) and Coxsackievirus A16 (CA16) Antigen Combo Rapid Test Kit EUDAMED
- Device Name
- Enterovirus 71 (EV71) and Coxsackievirus A16 (CA16) Antigen Combo Rapid Test Kit EUDAMED
- Model / Reference
- GKPD128 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-GKPD128XL EUDAMED
- Basic UDI-DI
- B-GKPD128XL EUDAMED
- EMDN Code
- W0105090699 OTHER MULTIPLE PATHOGENS - 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
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
Enterovirus 71 (EV71) and Coxsackievirus A16 (CA16) Antigen Combo Rapid Test Kit by Dezhou Guoke Medical Technology Co., Ltd. — Class IVD General — IVDD…
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-GKPD128XL | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dezhou Guoke Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000044128
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 1c679f87-db8f-4f97-af83-1840d8ae9c37 61 fields · synced Oct 5, 2026