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SARS-CoV-2 / Flu A / Flu B/ ADV Ag Combo Rapid Test Kit
EUDAMEDClass IVD General (EU MDR)
Ref GKPD107Ref GISF-702Model GISF
Identity
- Trade Name
- SARS-CoV-2 / Flu A / Flu B/ ADV Ag Combo Rapid Test Kit EUDAMEDSARS-CoV-2/Flu A/Flu B Ag Rapid Test EUDAMED
- Device Name
- SARS-CoV-2 / Flu A / Flu B/ ADV Ag Combo Rapid Test Kit EUDAMEDSARS-CoV-2/Flu A/Flu B Ag Rapid Test EUDAMED
- Model / Reference
- GKPD107 EUDAMEDGISF EUDAMEDGISF-702 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-GKPD107XC EUDAMED06976202763040 EUDAMED
- Basic UDI-DI
- B-GKPD107XC EUDAMEDB-06976202763040 EUDAMED
- EMDN Code
- W0105090699 OTHER MULTIPLE PATHOGENS - RT & POC EUDAMEDW0105070599 MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMEDItaly EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMEDEUDAMED
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
SARS-CoV-2 / Flu A / Flu B/ ADV Ag Combo Rapid Test Kit 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-GKPD107XC | 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 (2)
- EUDAMED 0a8a4fc1-5be3-462a-8dca-e36db2e5802f 61 fields · synced Oct 6, 2026
- EUDAMED dc7c3b22-e86c-4766-9d1f-2cff5dce4985 61 fields · synced Jul 30, 2026