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Respiratory Syncytial Virus (RSV) IgM Ab Rapid Test Kit
EUDAMEDClass IVD General (EU MDR)
Ref GKPD102
Identity
- Trade Name
- Respiratory Syncytial Virus (RSV) IgM Ab Rapid Test Kit EUDAMED
- Device Name
- Respiratory Syncytial Virus (RSV) IgM Ab Rapid Test Kit EUDAMED
- Model / Reference
- GKPD102 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-GKPD102X2 EUDAMED
- Basic UDI-DI
- B-GKPD102X2 EUDAMED
- EMDN Code
- W0105099002 RSV - 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
Respiratory Syncytial Virus (RSV) IgM Ab 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-GKPD102X2 | 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 786ce203-4fe3-4ede-9ef3-09016249d224 61 fields · synced Jun 18, 2026