IEsohunter
by Wuhan Ammunition Life-tech Co., Ltd. China EUDAMED
Ref AD10-24CE,Model 24 tests/kit
EMDN W01060299
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-AD10-24CE55 | Date9 Sep 2024 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/IVDD Expiring (legacy directive)
Specification
- Device Name
- Plasma DNA Methylation Detection Kit for Esophageal Cancer (Real-Time PCR)
- Model / Reference
- 24 tests/kit, AD10-24CE
- Primary DI / UDI-DI
- D-AD10-24CE55
- Basic UDI-DI
- B-AD10-24CE55
- EMDN Code
- W01060299 Tests for acquired genetic or chromosomal alterations - other
- Device Class
- Class IVD General
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000037251
- Authorised representative
- Kingsmead Service B.V. NL-AR-000002066
Other devices from Wuhan Ammunition Life-tech Co., Ltd.
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 7b7c232f-a085-4f7e-abee-af12e88ea0d0