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Siemens Healthcare Diagnostic Products GmbH

Germany · Marburg

✓ Record-verifiedregistrations found in 11 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 11 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

175listed device types

Class I 39Class II 132Class III 4

plus 325 registration records and 62 510(k), 69 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

396registered devices

Class I 72Class II 324

552 including historic records

SASaudi ArabiaSFDA

3registered imported devices

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

CACanadaMDALL

62active device licences

Class II 44Class III 16Class IV 2

340 including historic records

TWTaiwanTFDA

100valid device licences

Class I 13Class II 87

SGSingaporeHSA SMDR

88device registrations

CLASS B 74CLASS C 14

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

IVD import 2

AUAustraliaTGA ARTG

24active ARTG entries

IVD Class 1 5IVD Class 2 19

HKHong KongMDACS

8valid listings

IVD C 8

ILIsraelAMAR

94registrations

RURussiaRoszdravnadzor

91active registrations

Class 1 16Class 2a 28Class 2b 47

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 States325 registration records, 62 510(k), 69 PMA, 59 excluded

Brazil396 confirmed, 43 excluded

Saudi Arabia3 confirmed, 0 excluded

Canada62 confirmed, 13 excluded

Manufacturer names merged into this page: Siemens Healthcare Diagnostics Products GmbH · SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED · Siemens Healthcare Limited · Siemens Healthcare GmbH · SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH · SIEMENS HEALTHCARE GMBH

FDA 510(k) clearances by year

12013

72016

92017

42018

22019

12020

52021

72022

92023

52024

72025

52026

FDA listed device types

showing 8 of 175

Radioimmunoassay, Acth 1Fibrinogen Determination Standards And Controls 1Cardiac C-Reactive Protein, Antigen, Antiserum, And Control 1Plasma, Control, Normal 1Iga, Antigen, Antiserum, Control 1Enzyme Immunoassay, Diphenylhydantoin 1System, Fibrinogen Determination 1Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253985	INNOVANCE® D-Dimer 2.0 (SMN 10873803)	2026-08-11
US	K253264	myAblation Guide (VC10A)	2026-06-16
US	K253689	syngo Dynamics (VA41F)	2026-04-10
BR	80015490170	INNOVANCE vWF Ac	Class II
BR	80015490171	Coagulation Factor V Deficient Plasma	Class II
BR	80015490172	Thromboclotin	Class II
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