OC-Auto Sampling Bottle 4 RED
Ref VCPZ47Model OC-Auto Sampling Bottle 3
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 | Number4987026TD-OCSBZH | Date20 May 2022 | StatusActive |
Certificates
No notified-body 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- Withdrawn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
- Model / Reference
- OC-Auto Sampling Bottle 3, VCPZ47
- Primary DI / UDI-DI
- 04987026367774
- Basic UDI-DI
- 4987026TD-OCSBZH
- EMDN Code
- W05019001 Faeces collection devices
- Device Class
- Class A
- Market of Registration
- Belgium
Manufacturer details
- EUDAMED SRN
- JP-MF-000018097
- Authorised representative
- Advena Limited MT-AR-000000234
Other devices from Eiken Chemical Co., Ltd.
Properties
Other properties (9)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No