Multiple Real-Time PCR Detection Kit for Helicobacter Pylori Resistance Gene
by Beijing Applied Biological Technologies Co., Ltd. China EUDAMED
Ref CT8233-24T
EMDN W0105010499
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | NumberB-06974323012290 | Date15 Apr 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Multiple Real-Time PCR Detection Kit for Helicobacter Pylori Resistance Gene
- Model / Reference
- CT8233-24T
- Primary DI / UDI-DI
- 06974323012290
- Basic UDI-DI
- B-06974323012290
- EMDN Code
- W0105010499 H. pylori reagents - other
- Device Class
- Class IVD General
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000012338
- Authorised representative
- Luxus Lebenswelt GmbH DE-AR-000005110
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Properties & raw data
Show properties, registry sources and raw records
Other properties (8)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (1)
- EUDAMED 5539ca06-fea9-4e3c-9c47-0605a0a24cfc