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Instrumentation Laboratory Company

Italy · Bedford

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, Singapore, Hong Kong, Israel — 6 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

96listed device types

Class I 14Class II 81Class III 0unclassified 1

plus 379 registration records and 339 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

97registered devices

Class I 8Class II 89

115 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

78active device licences

Class II 56Class III 22

187 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

53device registrations

CLASS B 38CLASS C 15

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

37valid listings

IVD B 21IVD C 16

ILIsraelAMAR

3registrations

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 States379 registration records, 339 510(k), 0 PMA, 40 excluded

Brazil97 confirmed, 2 excluded

Saudi Arabia0 confirmed, 2 excluded

Canada78 confirmed, 5 excluded

Manufacturer names merged into this page: INSTRUMENTATION LABORATORY SPA · INSTRUMENTATION LABORATORY CO. · INSTRUMENTATION LABORATORY CO. - Devens · Instrumentation Laboratory SpA · INSTRUMENTATION LABORATORY · INSTRUMENTATION LABORATORY COMPANY

FDA 510(k) clearances by year

62007

32008

42009

52010

42011

22012

12013

42014

22015

92016

42017

12018

32019

22020

12021

32022

72023

12024

22025

22026

FDA listed device types

showing 8 of 96

Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm) 1Complement C1q, Antigen, Antiserum, Control 1Plasma, Control, Normal 1Auto-Antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/Prothrombin Complex 1Oximeter To Measure Hemoglobin 1System, Fibrinogen Determination 1Calibrator, Multi-Analyte Mixture 1Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260551	HemosIL Factor V Leiden (APC Resistance V)	2026-03-20
US	K253957	HemosIL Silica Clotting Time	2026-01-09
US	K251968	HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL	2025-07-24
BR	80003610254	HEMOSIL ELECTRACHROME FATOR VIII	Class II
BR	80003610615	GEM Premier 7000	Class II
BR	80003610043	IL TESTE EMULSAO DE REFERENCIA	Class I
CA	2848	IL PHOENIX ELECTROLYTE/CHEMISTRY SYSTEM	Class II
CA	3912	IL 237 TONOMETER	Class II
CA	3916	ILYTE	Class II

Instrumentation Laboratory Company

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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