ICervsure
by Wuhan Ammunition Life-tech Co., Ltd. China EUDAMED
Ref AD02-48CEModel 48 tests/kit
EMDN W01060299
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-AD02-48CE6G | Date9 Sep 2024 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/IVDD Expiring (legacy directive)
Specification
- Device Name
- DNA Methylation Detection Kit for Cervical Cancer(Real-Time PCR)
- Model / Reference
- 48 tests/kit, AD02-48CE
- Primary DI / UDI-DI
- D-AD02-48CE6G
- Basic UDI-DI
- B-AD02-48CE6G
- 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 82147926-9b7c-4ce8-ba96-27b5c59e3b6d