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SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD.

China · Shanghai

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

pendingnot queried

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

10listed device types

Class I 1Class II 9Class III 0

plus 43 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

11 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

6active device licences

Class II 2Class III 4

19 including historic records

TWTaiwanTFDA

5valid device licences

Class I 1Class II 4

SGSingaporeHSA SMDR

15device registrations

CLASS C 15

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

5active ARTG entries

IIb 5

HKHong KongMDACS

8valid listings

Class III 8

ILIsraelAMAR

7registrations

RURussiaRoszdravnadzor

13active registrations

Class 2b 13

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 States43 registration records, 5 510(k), 0 PMA, 69 excluded

Brazil0 confirmed, 52 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada6 confirmed, 15 excluded

Manufacturer names merged into this page: SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD. · SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD.

FDA 510(k) clearances by year

11999 · K984634

22000 · K994231

22001 · K012202

FDA listed device types

showing 8 of 10

Device, Beam Limiting, X-Ray, Diagnostic 1Image-Intensified Fluoroscopic X-Ray System, Mobile 1System, Image Processing, Radiological 1Solid State X-Ray Imager (Flat Panel/Digital Imager) 1System, X-Ray, Tomography, Computed 1System, X-Ray, Stationary 1Interventional Fluoroscopic X-Ray System 1System, X-Ray, Angiographic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K012202	NUMARIS 4VA15A	2001-09-27
US	K010721	AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM	2001-03-30
US	K994231	SIEMENS INTEGRATED OPERATING SYSTEM (SIOS)	2000-08-10
CA	67738	AXIOM ARTIS U - ANGIOGRAPHIC X-RAY SYSTEM	Class III
CA	68199	SOMATOM SPIRIT	Class III
CA	74853	SOMATOM EMOTION 16-SLICE CONFIGURATION	Class III

SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD.

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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