A-400 IgG
Ref 7-403Model A-400 IgG
A-400 IgG (7-403) is a device classified as IVD General made by PZ CORMAY Spółka Akcyjna, registered in EUDAMED on 21 Jul 2025 (Basic UDI-DI B-05907514674039), active as of 22 Oct 2026.
Active
CE IVDD
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-05907514674039 05907514674039 | Date21 Jul 2025 | StatusActive |
Official records
- EUDAMED public site B-05907514674039
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- Withdrawn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
- IgG
- Model / reference
- A-400 IgG, 7-403
- Primary DI / UDI-DI
- 05907514674039
- Basic UDI-DI
- B-05907514674039
- EMDN code
- W0102010105 Immunoglobulin g
- Device class
- Class IVD General
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- Poland
Manufacturer details
- EUDAMED SRN
- PL-MF-000023053
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