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Vibrio cholerae O1 and O139 Antigen Rapid Test Kit
EUDAMEDClass IVD General (EU MDR)
Ref GKPD127
Identity
- Trade Name
- Vibrio cholerae O1 and O139 Antigen Rapid Test Kit EUDAMED
- Device Name
- Vibrio cholerae O1 and O139 Antigen Rapid Test Kit EUDAMED
- Model / Reference
- GKPD127 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-GKPD127XJ EUDAMED
- Basic UDI-DI
- B-GKPD127XJ EUDAMED
- EMDN Code
- W0105011799 BACTERIOLOGY IMMUNOASSAY - OTHER 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
Vibrio cholerae O1 and O139 Antigen 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-GKPD127XJ | 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 34a924bf-d864-48f6-966c-f79009f32e81 61 fields · synced Jun 19, 2026