IColohunter
by Wuhan Ammunition Life-tech Co., Ltd. China EUDAMED
Ref AD06-96CE, AD06-24CEModel 96 tests/kit., 24 tests/kit
EMDN W01060214
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-AD06-96CE8V | 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 Colorectal Cancer (Real-Time PCR)
- Model / Reference
- 96 tests/kit., AD06-96CE, 24 tests/kit, AD06-24CE
- Primary DI / UDI-DI
- D-AD06-96CE8V, D-AD06-24CE72
- Basic UDI-DI
- B-AD06-96CE8V, B-AD06-24CE72
- EMDN Code
- W01060214 Colorectal cancer (msi-h / dmmr)
- 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
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 (2)
- EUDAMED 1fdf38d5-4314-4d34-8da1-526a632a611b
- EUDAMED D-AD06-24CE72|B-AD06-24CE72