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Influenza A/B, SARS-CoV-2, RSV, Adenovirus, Measles Virus, Mumps Virus and HPIV…
EUDAMEDClass IVD General (EU MDR)
Ref GKPD111Ref IS-MY-010-5Model 5 Tests/kitRef IS-MY-010-1Model 1 test/kitRef IS-MY-010-20Model 20 tests/kit
Identity
- Trade Name
- Influenza A/B, SARS-CoV-2, RSV, Adenovirus, Measles Virus, Mumps Virus and HPIV Antigen Combo Rapid Test Kit EUDAMEDSARS-CoV-2 /Influenza A/B virus antigen Rapid Test kit EUDAMED
- Device Name
- Influenza A/B, SARS-CoV-2, RSV, Adenovirus, Measles Virus, Mumps Virus and HPIV Antigen Combo Rapid Test Kit EUDAMEDSARS-CoV-2 /Influenza A/B virus antigen Rapid Test kit EUDAMED
- Model / Reference
- GKPD111 EUDAMED5 Tests/kit EUDAMEDIS-MY-010-5 EUDAMED1 test/kit EUDAMEDIS-MY-010-1 EUDAMED20 tests/kit EUDAMEDIS-MY-010-20 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-GKPD111X3 EUDAMED06974677691691 EUDAMED06974677691684 EUDAMED06974677691707 EUDAMED
- Basic UDI-DI
- B-GKPD111X3 EUDAMEDB-06974677691691 EUDAMEDB-06974677691684 EUDAMEDB-06974677691707 EUDAMED
- EMDN Code
- W0105090699 OTHER MULTIPLE PATHOGENS - RT & POC EUDAMEDW0105099099 VIROLOGY - RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMEDSpain 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
Influenza A/B, SARS-CoV-2, RSV, Adenovirus, Measles Virus, Mumps Virus and HPIV… 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-GKPD111X3 | 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 (4)
- EUDAMED 3b479b5e-067a-4ea2-9f78-056240dafc48 61 fields · synced Oct 6, 2026
- EUDAMED 5d0994f0-6466-44be-8758-a63959ab7a17 61 fields · synced Jul 9, 2026
- EUDAMED de65dc6c-9c9b-42a5-8399-c4c679bf77e3 61 fields · synced Jul 14, 2026
- EUDAMED c259e0c5-3246-45b2-a99b-4b199901e94b 61 fields · synced Jul 27, 2026