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Fisher Diagnostics

USA · Middletown

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore — 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

118listed device types

Class I 39Class II 78Class III 0unclassified 1

plus 182 registration records and 16 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

6registered devices

Class I 2Class II 4

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

33active device licences

Class II 33

75 including historic records

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

16device registrations

CLASS B 14CLASS C 2

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 States182 registration records, 16 510(k), 0 PMA, 30 excluded

Brazil6 confirmed, 14 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada33 confirmed, 8 excluded

Manufacturer names merged into this page: Fisher Diagnostics · FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, L.L.C. · FISHER DIAGNOSTICS · REAL: THERMO FISHER SCIENTIFIC PARA SIEMENS HEALTHCARE DIAGNOSTICS INC. · FISHER SCIENTIFIC - EUA PARA SIEMENS HEALTHCARE DIAGNOSTICS INC. - EUA

FDA 510(k) clearances by year

11983

21984

31985

12001

22002

22004

12005

22006

12007

12017

FDA listed device types

showing 8 of 118

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	72019	OXALATE TEST KIT	Class II
CA	72020	CREATININE REAGENT - ENZYMATIC	Class II
CA	72292	LDL CHOLESTEROL REAGENT	Class II

Fisher Diagnostics

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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