Diagenode S.A.
Active in EUDAMEDBelgiumfrom SRN EUDAMED FDA SRN BE-MF-000015361 FEI 3010534606
- Devices
- 7
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA FEI
Catalogue
Panther Fusion EBV Quant Assay Calibrators Ref PRD-07159
Regimes: CE IVDR Registry: EUDAMEDPanther Fusion EBV Quant Assay Ref PRD-07157
Regimes: CE IVDR Registry: EUDAMEDPanther Fusion EBV-BKV Quant Assays Controls Kit Ref PRD-07158
Regimes: CE IVDR Registry: EUDAMEDPanther Fusion Bordetella Assay Ref PRD-04868
Regimes: CE IVDR Registry: EUDAMEDPanther Fusion BKV Quant Assay - BKV Reagent Cartridge Ref PRD-07232
Regimes: CE IVDR Registry: EUDAMEDPanther Fusion Bordetella Controls kit Ref PRD-04869
Regimes: CE IVDR Registry: EUDAMEDPanther Fusion BKV Quant Assay Calibrators Ref PRD-07234
Regimes: CE IVDR Registry: EUDAMED
Company details
- EUDAMED SRN
- BE-MF-000015361
- FDA FEI number
- 3010534606
- EU VAT number
- 0480.422.786
- EUDAMED status
- Active
- EUDAMED registered name
- Diagenode S.A.
- Registered address
- 3, Rue du bois Saint Jean, 4102, Seraing, Belgium
- [email protected]
- Phone
- +3243642050
- PRRC contact
- Romy Zaletelj
EUDAMED certificates
1 certificate1 valid, 0 expiredIVDR 1next expiry 2 Aug 2031
Notified body 2797 1 certificate
- IVDR 782617 Active
Quality management system EU IVDR
- Issued
- 3 Aug 2026
- Expires
- 2 Aug 2031
Frequently asked questions
How many devices does Diagenode S.A. have in the registry?
The registry currently lists 7 devices for Diagenode S.A.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Diagenode S.A.'s devices?
Among its 7 most recently registered devices, Diagenode S.A. has devices listed in EUDAMED (7 devices).
What risk classes do Diagenode S.A.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Diagenode S.A.'s devices are IVDR Class B and IVDR Class C. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Diagenode S.A.?
EUDAMED lists 1 certificate for Diagenode S.A. (quality management system) under IVDR. 1 is recorded with the status issued. The most recent was issued on 2026-08-03.
What are the newest devices from Diagenode S.A. in the registry?
The most recently registered devices listed for Diagenode S.A. include Panther Fusion EBV Quant Assay Calibrators, Panther Fusion EBV Quant Assay, Panther Fusion EBV-BKV Quant Assays Controls Kit and Panther Fusion Bordetella Assay.