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Siemens Healthcare s.r.o.

Slovakia · Kosice-Barca Kosicky

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong — 9 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

363listed device types

Class I 99Class II 254Class III 5unclassified 5

plus 1,365 registration records and 309 510(k), 443 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1,038registered devices

Class I 201Class II 837

1,679 including historic records

SASaudi ArabiaSFDA

3registered imported devices

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

CACanadaMDALL

185active device licences

Class II 145Class III 35Class IV 5

656 including historic records

TWTaiwanTFDA

3valid device licences

Class I 3

SGSingaporeHSA SMDR

85device registrations

CLASS B 32CLASS C 53

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

4active ARTG entries

Class I 1IIb 3

HKHong KongMDACS

41valid listings

Class II 6Class III 35

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 States1,365 registration records, 309 510(k), 443 PMA, 50 excluded

Brazil1,038 confirmed, 15 excluded

Saudi Arabia3 confirmed, 0 excluded

Canada185 confirmed, 12 excluded

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

FDA 510(k) clearances by year

222008

322009

172010

282011

122012

192013

272014

192015

172016

202017

122018

102019

72020

102021

82022

182023

102024

112025

102026

FDA listed device types

showing 8 of 363

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	K253985	INNOVANCE® D-Dimer 2.0 (SMN 10873803)	2026-08-11
US	K253528	Atellica IM CA 19-9 II	2026-08-10
US	K261364	Atellica CH Acetaminophen 2 (ACTM)	2026-07-24
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	3739	CLOTTING FACTOR VIII DEFICIENT PLASMA	Class II
CA	3775	SCHISTOSE CELLOGNOST	Class II
CA	3841	ENZYGNOST F1+2 MICRO	Class II

Siemens Healthcare s.r.o.

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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