EXBIO Praha, a.s.
Active in EUDAMEDCzechiafrom SRN EUDAMED FDA SRN CZ-MF-000033468 FEI 3008794764
- Devices
- 12
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
EU certificates
2 of 2 in force.
Market reach
- European Union
- EUDAMED actor, 2 certificates
- United States
- FDA FEI
Catalogue
Search and filter all 12 devicesCompany details
- EUDAMED SRN
- CZ-MF-000033468
- FDA FEI number
- 3008794764
- EU VAT number
- CZ25548611
- EUDAMED status
- Active
- EUDAMED registered name
- EXBIO Praha, a.s.
- Registered address
- 341, Nad Safinou II, 25250, Vestec, Czechia
- Website
- www.exbio.cz
- [email protected]
- PRRC contact
- František Škrob
EUDAMED certificates
2 certificates2 valid, 0 expiredIVDR 2next expiry 11 Jun 2029
3EC International a.s. 2265 2 certificates
- 2024-IVDR/QS-004 Supplemented
Quality management system EU IVDR
- Issued
- 4 Dec 2024
- Expires
- 11 Jun 2029
- Reason
- Add device or group
- 2025-IVDR/QS-002 Issued
Quality management system EU IVDR
- Issued
- 30 Jun 2025
- Expires
- 11 Jun 2029
Frequently asked questions
How many devices does EXBIO Praha, a.s. have in the registry?
The registry currently lists 12 devices for EXBIO Praha, a.s.. Devices recorded under merged duplicate company entries are counted once.
Which registries list EXBIO Praha, a.s.'s devices?
Among its 12 most recently registered devices, EXBIO Praha, a.s. has devices listed in EUDAMED (12 devices).
What risk classes do EXBIO Praha, a.s.'s devices fall under?
Among its 12 most recently registered devices, the classes recorded for EXBIO Praha, a.s.'s devices are IVDR Class A, IVDR Class B, IVDR Class C and IVD general. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for EXBIO Praha, a.s.?
EUDAMED lists 2 certificates for EXBIO Praha, a.s. (quality management system) under IVDR. 1 is recorded with the status issued. The most recent was issued on 2025-06-30.
What are the newest devices from EXBIO Praha, a.s. in the registry?
The most recently registered devices listed for EXBIO Praha, a.s. include DryFlowEx TBNK 6-color, BasoFlowEx Kit, Common wasp venom (i3) and CD34 QuantiFlowEx Kit.