PIN Cocktail (P504S+p63)
by Zytomed Systems GmbH 4 variants
Ref COG001
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-COG0019A | Date16 Oct 2026 | 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- Withdrawn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/IVDD Active
Specification
- Model / Reference
- COG001
- Primary DI / UDI-DI
- D-COG0019A
- Basic UDI-DI
- B-COG0019A
- EMDN Code
- W01030709 Primary antisera for immunohistology
- Device Class
- Class IVD General
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000029785
Other devices from Zytomed Systems GmbH
Properties
Other properties (8)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No