← Back to catalogue
Treponema pallidum (TP) Antibody Detection Kit (Immunofluorescence Chromatograp…
EUDAMEDClass IVD General (EU MDR)
Ref GKPD157
Identity
- Trade Name
- Treponema pallidum (TP) Antibody Detection Kit (Immunofluorescence Chromatography) EUDAMED
- Device Name
- Treponema pallidum (TP) Antibody Detection Kit (Immunofluorescence Chromatography) EUDAMED
- Model / Reference
- GKPD157 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-GKPD157XT EUDAMED
- Basic UDI-DI
- B-GKPD157XT EUDAMED
- EMDN Code
- W0105010302 SYPHILIS ANTIBODY ASSAYS TOTAL 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
Treponema pallidum (TP) Antibody Detection Kit (Immunofluorescence Chromatograp… 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-GKPD157XT | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dezhou Guoke Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000044128
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 29cde2db-a217-4b13-a18e-8a097d1ef0a4 61 fields · synced Jul 11, 2026