Home›Italy›BIOMERIEUX ITALIA S.P.A.

BIOMERIEUX ITALIA S.P.A.

Italy · Ponte A Ema

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Taiwan — 3 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

pendingnot queried

USUnited StatesFDA openFDA

13listed device types

Class I 4Class II 9Class III 0

plus 5 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

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

1active device licences

Class II 1

TWTaiwanTFDA

3valid device licences

Class I 3

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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.

United States5 registration records, 0 510(k), 0 PMA, 18 excluded

Brazil0 confirmed, 12 excluded

Canada1 confirmed, 4 excluded

Manufacturer names merged into this page: BIOMERIEUX ITALIA-INDUSTRIAL DIV. · BIOMERIEUX ITALIA S.P.A.

FDA listed device types

showing 8 of 13

Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine 1Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii 1Visual, Pregnancy Hcg, Prescription Use 1Enzyme Linked Immunoabsorbent Assay, Rubella 1Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates 1Igg, Antigen, Antiserum, Control 1Reagent, Borrelia Serological Reagent 1Radioimmunoassay, Thyroid-Stimulating Hormone 1

BIOMERIEUX ITALIA S.P.A.

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

Similar companies