Plastic cassette
by Cangzhou Shengfeng Plastic Product Co., Ltd
Ref Single cassetteModel Single cassette; multi cassette; midstream cassette; panel cassette
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 | Number698031904PC001AK 06980319040000 | Date27 Jul 2026 | 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- Withdrawn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
- Plastic cassette
- Model / Reference
- Single cassette, multi cassette, midstream cassette, panel cassette
- Primary DI / UDI-DI
- 06980319040000
- Basic UDI-DI
- 698031904PC001AK
- EMDN Code
- W0101060699 Blood gas electrodes or cassette poc - other
- Device Class
- Class A
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000020600
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Cangzhou Shengfeng Plastic Product 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