Aquaflush® 200 Transanal Irrigation System – Standard Set
by Clinisupplies (Nanjing) Co., Ltd.
Ref AF2-F
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number5060463890247VC11FSL 05060458871619 | Date1 Dec 2022 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Aquaflush Transanal Irrigation System
- Model / Reference
- AF2-F
- Primary DI / UDI-DI
- 05060458871619
- Basic UDI-DI
- 5060463890247VC11FSL
- EMDN Code
- G99 Gastrointestinal devices - other
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000026449
- Authorised representative
- Advena Limited MT-AR-000000234
Other devices from Clinisupplies (Nanjing) Co., Ltd.
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No