Refill Solution
by Shenzhen Cornley Bio-Medical Co., Ltd. China EUDAMED
Ref /Model ISE Ⅰ,ISEⅡ
EMDN W0101060606
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697287382ISEWU | Date26 Jul 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Refill Solution
- Model / Reference
- ISE Ⅰ, ISEⅡ, /
- Primary DI / UDI-DI
- 06972873821508
- Basic UDI-DI
- 697287382ISEWU
- Direct Marketing DI
- 06972873821508
- EMDN Code
- W0101060606 Blood gas buffers and solutions - electrodes or cassette
- Device Class
- Class A
Manufacturer details
- EUDAMED SRN
- CN-MF-000017322
- Authorised representative
- Umedwings Netherlands B.V. NL-AR-000000444
Other devices from Shenzhen Cornley Bio-Medical Co., Ltd.
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Properties & raw data
Show properties, registry sources and raw records
Other properties (10)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED 2dfd0812-cbea-4389-a461-a255969ac03d