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SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LIMITED

Ireland · Swords Dublin

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, South Korea, Israel — 7 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

315listed device types

Class I 91Class II 214Class III 5unclassified 5

plus 1,082 registration records and 279 510(k), 374 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

562registered devices

Class I 101Class II 461

766 including historic records

SASaudi ArabiaSFDA

3registered imported devices

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

CACanadaMDALL

125active device licences

Class II 102Class III 20Class IV 3

469 including historic records

TWTaiwanTFDA

9valid device licences

Class I 9

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

IVD import 1

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States1,082 registration records, 279 510(k), 374 PMA, 57 excluded

Brazil562 confirmed, 43 excluded

Saudi Arabia3 confirmed, 0 excluded

Canada125 confirmed, 14 excluded

Manufacturer names merged into this page: Siemens Healthcare Diagnostics Inc · Siemens Healthcare Diagnostics Manufacturing Ltd. · SIEMENS HEALTHCARE DIAGNOSTICS INC. · Siemens Healthcare Diagnostics Inc. · SIEMENS HEALTHCARE GMBH · SIEMENS HEALTHCARE DIAGNOSTICS, INC.

FDA 510(k) clearances by year

222008

322009

172010

282011

122012

192013

272014

192015

112016

152017

102018

92019

62020

62021

52022

142023

82024

102025

92026

FDA listed device types

showing 8 of 315

Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) 1Container, Specimen, Sterile 1Test, Follicle Stimulating Hormone (Fsh), Over The Counter 1Gas, Calibration (Specified Concentration) 1Colorimetric Method, Triglycerides 1Prealbumin, Fitc, Antigen, Antiserum, Control 1Enzyme Immunoassay, Inhibin-A 1Bilirubin (Total And Unbound) In The Neonate Test System 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253528	Atellica IM CA 19-9 II	2026-08-10
US	K261364	Atellica CH Acetaminophen 2 (ACTM)	2026-07-24
US	K253264	myAblation Guide (VC10A)	2026-06-16
BR	10345160165	Calibrador A ADVIA Centaur / Atellica IM (Cal A)	Class II
BR	10345160057	Calibrador E ADVIA Centaur / Atellica IM (Cal E)	Class II
BR	10345160005	FAMÍLIA CA 19-9 DILUENT	Class I
SA	ME0000007466SFDAA00001	DirectBrachy Positioning Board	—
SA	ME0000004546SFDAA00098	teamplay Images VC30A	—
CA	10063	RAPID YEAST ID PANEL	Class II
CA	10212	TSSR TOUCHSCAN SONIC READER	Class II
CA	2744	CYCLIC AMP	Class II

SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LIMITED

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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