Saliva collector
by Jiangsu Comeon Medical Apparatus Co., Ltd 13 variants
Active
CE IVDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697563134KM001FQ | Date14 Sep 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- Withdrawn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/IVDR Active
Specification
- Device Name
- Saliva collector
- Primary DI / UDI-DI
- 16975631341208, 16975631341178, 16975631341123, 16975631341055, 16975631341246, 16975631341239, 16975631341154, 16975631341260, 16975631341031, 16975631341079, 16975631341222, 16975631341192, 16975631341284, 16975631341116, 16975631341277, 16975631341062
- Basic UDI-DI
- 697563134KM001FQ
- EMDN Code
- W05019002 Saliva collection devices
- Device Class
- Class A
- EU market of registration
- AustriaBelgium
Manufacturer details
- EUDAMED SRN
- CN-MF-000018384
- Authorised representative
- Sungo Cert GmbH DE-AR-000010869
Other devices from Jiangsu Comeon Medical Apparatus Co., Ltd
See all devices from Jiangsu Comeon Medical Apparatus Co., Ltd →
Properties
Other properties (10)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No