Cleanser
by Shenzhen Reetoo Biotechnology Co., Ltd China EUDAMED
Ref C00002-01Model CLE-F
EMDN W01029003
Overview
Introducing the Cleanser, a versatile and reliable device designed for near-patient testing and professional use. This sterile device features a unique instrumentation package and is available for medical professionals to administer medicinal products.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number6974675468010095 | Date30 May 2022 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- CLE-F, C00002-01
- Primary DI / UDI-DI
- 06974675460183
- Basic UDI-DI
- 6974675468010095
- EMDN Code
- W01029003 Buffers (unassignable), supplem. reagents, etc (ic)
- Device Class
- Class A
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- CN-MF-000011699
- Authorised representative
- Umedwings Netherlands B.V. NL-AR-000000444
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Properties & raw data
Show properties, registry sources and raw records
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED e84a9bda-aa35-4f57-8fa5-01dd270a1b14