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Home›Czechia›EXBIO Praha, a.s.

EXBIO Praha, a.s.

Czechia · Vestec · www.exbio.cz
✓ Record-verifiedregistrations found in 5 marketsEU SRN CZ-MF-000033468

This company has registrations in European Union, United States, United Kingdom, Brazil, Israel — 5 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
12UDI-DI device records
IVD A 4IVD B 1IVD C 6IVD general 1
USUnited StatesFDA openFDA
1listed device types
Class I 1Class II 0Class III 0
plus 1 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
7registered device records
IVD A 1IVD B 1IVD C 2IVD general 3
BRBrazilANVISA
1registered devices
Class I 1
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

European Union19 raw hits, 7 excluded, 12 confirmed
United States1 registration records, 0 510(k), 0 PMA
United Kingdom7 confirmed, 0 excluded
Brazil1 confirmed, 0 excluded
Manufacturer names merged into this page: EXBIO PRAHA, A.S.

Regulatory identity

EU manufacturer SRN
CZ-MF-000033468
UK responsible person
Sysmex UK Ltd

Company information

Country
Czechia
City
Vestec
Website
www.exbio.cz
Product categories
Clinical Diagnostics & Therapeutic TechnologiesLaboratory, IVD & DiagnosticsClinical chemistry & immunoassays

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

LEI
315700O9Y6AQQ5VA4E11
Registration status
Active
Legal form
Akciová společnost
Incorporated
1998-12-16
Registered address
Nad Safinou II 341, Vestec, 252 50
Registration authority
Commercial Register, no. 25548611
Registry record updated
2026-05-12

Business registration data from GLEIF, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA listed device types

Reagents, Specific, Analyte 1

Registration details (sample)

MarketIdentifierNameClass / date
EU08594208060017—IVD C
EU08594208060024—IVD C
EU08594208060031—IVD C
EU08594208060055—IVD C
UK61165EXCELLYSE IIVD A
UK56974CD34 QuantiFlowEx KitIVD general
UK64973BasoFlowEx KitIVD B
BR80500080005FAMÍLIA EXCELLYSEClass I

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