Home›Czechia›GENERI BIOTECH s.r.o.

GENERI BIOTECH s.r.o.

Czechia · Hradec Králové - Pražské Předměstí · www.generi-biotech.com

✓ Record-verifiedregistrations found in 2 marketsEU SRN CZ-MF-000018857

This company has registrations in European Union, Israel — 2 overseas markets. EU UDI-DI records ≥14, the first 300 verified individually. 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

≥14UDI-DI device records

IVD C 14

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

0listed device types

Class I 0Class II 0Class III 0

plus 0 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

0registered devices

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

1registrations

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 Union339 raw hits, 286 excluded, 14 confirmed. Large result set — only the first 300 verified

United Kingdom0 confirmed, 1 excluded

Regulatory identity

EU manufacturer SRN: CZ-MF-000018857

Business registration

LEI: 9845002BDD77FF4DFD10
Registration status: Active
Legal form: Společnost s ručením omezeným
Incorporated: 1995-06-08
Registration authority: Commercial Register, no. 63221667
Registry record updated: 2025-11-29

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

Market	Identifier	Name	Class / date
EU	08595223925022	gb PHARM Warfarin	IVD C
EU	08595223925015	gb PHARM Warfarin	IVD C
EU	08595223925114	gb GENETIC A1AT	IVD C
EU	08595223925213	gb GENETIC FRUCTO	IVD C

GENERI BIOTECH s.r.o.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

Registration details (sample)

Similar companies