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INTERLAB S. R. L.

Italy · Roma

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Hong Kong, Russia — 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

pendingnot queried

USUnited StatesFDA openFDA

4listed device types

Class I 1Class II 3Class III 0

plus 1 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

27registered devices

Class I 1Class II 26

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

9 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

2valid listings

IVD B 2

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

4active registrations

Class 1 1Class 2a 3

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 States1 registration records, 4 510(k), 0 PMA, 1 excluded

Brazil27 confirmed, 0 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: INTERLAB S.R.L. · INTERLAB S. R. L.

FDA 510(k) clearances by year

12003 · K033187

22004 · K040146

12006 · K053571

FDA listed device types

Kappa, Antigen, Antiserum, Control 1Immunoelectrophoretic, Immunoglobulins, (G, A, M) 1Lambda, Antigen, Antiserum, Control 1Electrophoretic, Protein Fractionation 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K053571	MICROGEL ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, MICROGEL ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM	2006-06-30
US	K040146	INTERLAB ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM	2004-05-04
US	K032862	INTERLAB ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM	2004-02-03
BR	80189860214	INTERLAB G26	Class II
BR	80189860253	ISOENZIMAS FOSFATASE ALCALINA	Class II
BR	80416660069	KIT ELETROFORESE DE LIPOPROTEÍNAS	Class II
CA	78932	AUTOMATED AGAROSE GEL ELECTROPHORESIS SYSTEMS	Class II

INTERLAB S. R. L.

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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