Erg (QR040)
by biocyc Biotechnologie GmbH & Co. KG 6 variants
Ref C-E003-025, C-E003-05
Erg (QR040) (C-E003-025) is a device classified as IVD General made by biocyc Biotechnologie GmbH & Co. KG, registered in EUDAMED on 16 Oct 2023 (Basic UDI-DI B-C-E003-025HJ), active as of 7 Nov 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-C-E003-025HJ | Date16 Oct 2023 | StatusActive |
Official records
- EUDAMED public site B-C-E003-025HJ
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- Withdrawn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
- Model / reference
- C-E003-025, C-E003-05
- Primary DI / UDI-DI
- D-C-E003-025HJ, D-C-E003-05Z2
- Basic UDI-DI
- B-C-E003-025HJ, B-C-E003-05Z2
- EMDN code
- W01030709 Primary antisera for immunohistology
- Device class
- Class IVD General
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000031533
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