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Siemens Healthineers Ltd.

China · 上海 · www.siemens-healthineers.com

✓ Record-verifiedregistrations found in 10 marketsEU SRN DE-PR-000038457Unified social credit code 91310000MA1K32L88E

This company holds 32 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, South Korea, Australia, Hong Kong — 9 overseas markets. EU UDI-DI records ≥2, the first 300 verified individually.

Registrations by market

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

CNChinaNMPA

32China registrations

Class II 2Class III 29

as of 2026-09-01 · showing 30 of the detail records

EUEuropean UnionEUDAMED

≥2UDI-DI device records

Class IIb 2

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

69listed device types

Class I 8Class II 60Class III 1

plus 601 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

8registered device records

Class IIa 3Class IIb 4System or Procedure Pack 1

BRBrazilANVISA

4registered devices

Class 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

0active device licences

12 including historic records

TWTaiwanTFDA

59valid device licences

Class I 2Class II 57

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

12GMP quality-system certificates

Import 12

AUAustraliaTGA ARTG

21active ARTG entries

IIa 6IIb 15

HKHong KongMDACS

1valid listings

Class III 1

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.

European Union777 raw hits, 298 excluded, 2 confirmed. Large result set — only the first 300 verified

United States601 registration records, 7 510(k), 0 PMA

China32 certificates (Class III 29 / II 2 / I 0), as of 2026-09-01

United Kingdom8 confirmed, 0 excluded

Brazil4 confirmed, 0 excluded

Manufacturer names merged into this page: Siemens Healthineers AG · Siemens Healthineers AG Varian Cancer Therapy (CTH) · Siemens Healthineers Ltd. · SIEMENS HEALTHINEERS AG

Regulatory identity

EU manufacturer SRN: DE-PR-000038457
UK responsible person: Siemens Healthcare Limited
Unified social credit code: 91310000MA1K32L88E
Exhibition record: CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Business registration

Registration status: Active
Incorporated: 2015-11-19
Registered capital: CNY 249,205,000
Paid-in capital: CNY 249,205,000
Legal form: Limited liability company (wholly owned by a foreign corporation)
Industry classification: Wholesale trade
Last approval date: 2026-04-30

Business registration data from Tianyancha, as of 2026-09-02. Public registry information only; legal representative and contact-person details are not collected. The figure is the number of employees enrolled in social insurance as declared by the company, which may differ from actual headcount.

FDA 510(k) clearances by year

12019 · K183575

12024 · K241898

22025 · K253495

32026 · K260852

FDA listed device types

showing 8 of 69

Detector And Alarm, Arrhythmia 1System, Planning, Radiation Therapy Treatment 1Densitometer, Bone 1Solid State X-Ray Imager (Flat Panel/Digital Imager) 1System, X-Ray, Mobile 1Amplifier And Signal Conditioner, Transducer Signal 1Radiological Image Processing Software For Ablation Therapy Planning And Evaluation 1Biopsy Needle Guide Kit 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	国械注进20173061251	正电子发射及X射线计算机断层成像系统PET/CT	Class III · 2026-03-16
CN	国械注进20173062264	正电子发射及X射线计算机断层成像系统PET/CT	Class III · 2025-12-19
CN	国械注进20253060483	一次性使用心腔内超声导管AcuNav Lumos 4D ICE Catheter	Class III · 2025-10-27
CN	国械注进20173061250	正电子发射及X射线计算机断层成像系统PET/CT	Class III · 2025-09-29
EU	04068151051551	SOMATOM X.cite Combination AG	Class IIb
EU	04068151090086	Syngo Carbon Enterprise Access	Class IIb
UK	40867	AI-Rad Companion Chest CT	Class IIb
UK	37618	SOMATOM X.ceed	Class IIb
UK	37618	Somatom x.ceed combination	System or Procedure Pack
US	K260852	MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.Pure	2026-07-31
US	K253690	LungMaps	2026-06-15
US	K253023	BIOGRAPH One	2026-01-15
BR	10345162321	Equipamento de Ressonância Magnética MAGNETOM	Class II
BR	10345169018	Equipamento de Ressonância Magnética MAGNETOM Flow.Elite	Class II
BR	10345169017	Equipamento de Ressonância Magnética MAGNETOM Viato.Mobile	Class II

Siemens Healthineers Ltd.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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