BCA-225 (Cu-18)
Ref Z2141MS
Active
CE IVDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-00840140700787 00840140700787 | Date31 Mar 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- Withdrawn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/IVDD Active
Specification
- Device Name
- Bca-225
- Model / Reference
- Z2141MS
- Primary DI / UDI-DI
- 00840140700787
- Basic UDI-DI
- B-00840140700787
- EMDN Code
- W01030709 Primary antisera for immunohistology
- Device Class
- Class IVD General
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- US-MF-000008650
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Zeta Corporation
Properties
Other properties (8)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No