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Treponema Pallidum Antibody Rapid Test Cassette(Colloidal Gold Method)
EUDAMEDClass IVD General (EU MDR)
Ref IH018
Identity
- Device Name
- Treponema Pallidum Antibody Rapid Test Cassette(Colloidal Gold Method) EUDAMED
- Model / Reference
- IH018 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974323018681 EUDAMED
- Basic UDI-DI
- B-06974323018681 EUDAMED
- EMDN Code
- W0105010303 SYPHILIS ANTIBODY IGG EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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 Antibody Rapid Test Cassette(Colloidal Gold Method) by Beijing Applied Biological Technologies 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-06974323018681 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Beijing Applied Biological Technologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000012338
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED 1e6938ec-44a0-49cf-b6d2-3a4e0bc106fe 61 fields · synced Jun 19, 2026