Home›USA›FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, L.L.C.

FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, L.L.C.

USA · Middletown

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, South Korea, Australia, Israel, Russia — 8 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

119listed device types

Class I 40Class II 78Class III 0unclassified 1

plus 183 registration records and 105 510(k), 1 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class I 1Class II 3

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

36active device licences

Class II 36

85 including historic records

TWTaiwanTFDA

26valid device licences

Class I 23Class II 3

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

12GMP quality-system certificates

IVD import 12

AUAustraliaTGA ARTG

5active ARTG entries

IVD Class 2 5

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

1active registrations

Class 2a 1

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 States183 registration records, 105 510(k), 1 PMA, 28 excluded

Brazil4 confirmed, 16 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada36 confirmed, 7 excluded

Manufacturer names merged into this page: Fisher Diagnostics · FISHER SCIENTIFIC COMPANY L.L.C. · FISHER SCIENTIFIC · FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, L.L.C. · FISHER DIAGNOSTICS

FDA 510(k) clearances by year

171979

81980

61981

61982

211983

81984

71985

41986

31987

11988

11989

21992

11993

12001

22002

22004

12005

22006

12007

12017

FDA listed device types

showing 8 of 119

Counter, Differential Cell 1Igm, Antigen, Antiserum, Control 1Turbidimetric, Total Protein 1Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens 1Plasma, Control, Normal 1Catalytic Methods, Amylase 1Iga, Antigen, Antiserum, Control 1Enzyme Immunoassay, Diphenylhydantoin 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K170652	ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls	2017-06-01
US	K070640	ARCHITECT STAT TROPONIN-1; MYOGLOBIN	2007-09-13
US	K052407	ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS	2006-07-18
BR	10033120800	Infinity Ammonia Reagente For Beckman Coulter AU Chemistry Analyzers	Class II
BR	80146501989	Lactic Acid	Class II
BR	80146502095	Alinity c Lactic Acid Reagent Kit	Class II
CA	326	FISHERBRAND NITRILE EXAMINATION GLOVE, POWDERED	Class II
CA	64177	FISHERBRAND SYNTHETIC, NON-LATEX EXAMINATION GLOVES	Class II
CA	64178	FISHERBRAND SYNTHETIC, NON-LATEX EXAMINATION GLOVES	Class II

FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, L.L.C.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies