Authorised representative profile

Siemens Healthcare Limited

西门子医疗有限公司

Hong Kong MDACS177 represented devices20 applicantsNov 22, 2011 – Sep 24, 2024

VerifiedMDD (Medical Device Division) · MDACS registry

177

Total devices

20

Applicants

2011

First representation

2024

Most recent

AR overview

Authorised representative (EN): Siemens Healthcare Limited
Authorised representative (ZH): 西门子医疗有限公司
Phone: 25833388

Timeline

First representation: Nov 22, 2011
Most recent: Sep 24, 2024

Regulatory footprint

Search Siemens Healthcare Limited across other regulatory registries

Risk class distribution

D20

C17

B21

II38

III80

IV1

Applicant partnerships

Top manufacturers represented by this AR

Siemens Healthcare GmbH

Siemens Healthcare Diagnostics Inc.

Siemens Shanghai Medical Equipment Ltd.

Siemens Medical Solutions USA, Inc.

Siemens Shenzhen Magnetic Resonance Ltd.

Siemens Healthcare Diagnostics Inc

Siemens Healthcare Diagnostics Products Limited

Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc. Molecular Imaging

Recent registrations

Latest 15 MDACS listings represented by Siemens Healthcare Limited

Radiographic Systems

射线照相系统

Risk class: III
Applicant: Siemens Shanghai Medical Equipment Ltd.上海西门子医疗器械有限公司

IVD Test Reagent/Kits, Clinical Chemistry, Trace Metal, Iron

体外诊断测试试剂/试剂盒、临床化学、痕量金属、铁

Risk class: B
Applicant: Siemens Healthcare Diagnostics IncSiemens Healthcare Diagnostics Inc

Radiographic/Fluoroscopic Systems, Angiography/Interventional

放射/透视系统,血管造影/介入

Risk class: III
Applicant: Siemens Healthcare GmbHSiemens Healthineers

IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Carbohydrate Antigen CA 27.29

体外诊断检测试剂/试剂盒、免疫检测、肿瘤标志物、碳水化合物抗原 CA 27.29

Risk class: C
Applicant: Siemens Healthcare Diagnostics Inc.Siemens Healthcare Diagnostics Inc

IVD Test Reagent/Kits, Immunoassay, Renal Metabolism, Cortisol

体外诊断测试试剂/试剂盒、免疫测定、肾脏代谢、皮质醇

Risk class: B
Applicant: Siemens Healthcare Diagnostics Inc.Siemens Healthcare Diagnostics Inc

IVD Test Reagent/Kits, Clinical Chemistry, Enzyme, Gamma Glutamyltransferase

体外诊断测试试剂/试剂盒、临床化学、酶、γ-谷氨酰转移酶

Risk class: B
Applicant: Siemens Healthcare Diagnostics Inc.Siemens Healthcare Diagnostics Inc

IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Breast Cancer

体外诊断检测试剂/试剂盒, 免疫测定, 肿瘤标志物, 乳腺癌

Risk class: C
Applicant: Siemens Healthcare Diagnostics Inc.Siemens Healthcare Diagnostics Inc

IVD Test Reagent/Kits, Serology, Virus, Hepatitis A, Antibody

体外诊断检测试剂/试剂盒、血清学、病毒、甲型肝炎、抗体

Risk class: B
Applicant: Siemens Healthcare Diagnostics Inc.Siemens Healthcare Diagnostics Inc

Radiographic/Fluoroscopic Units, Mobile

射线照相/透视装置,移动式

Risk class: III
Applicant: Siemens Healthcare GmbHSiemens Healthineers

Scanning Systems, Ultrasonic, General-Purpose

超声波、通用扫描系统

Risk class: II
Applicant: Siemens Medical Solutions USA, IncSiemens Medical Solutions Usa , Inc.

Scanning Systems, Computed Tomography

扫描系统,计算机断层扫描

Risk class: III
Applicant: Siemens Shanghai Medical Equipment Ltd.上海西门子医疗器械有限公司

IVD Test Reagent/Kits, Serology, Bacteria, Streptococcus Species, Antibody, Streptolysin O

体外诊断检测试剂/试剂盒, 血清学, 细菌, 链球菌属, 抗体, 链球菌溶血素 O

Risk class: B
Applicant: Siemens Healthcare Diagnostic Inc.Siemens Healthcare Diagnostic Inc.

Scanning Systems, Computed Tomography

扫描系统,计算机断层扫描

Risk class: III
Applicant: Siemens Healthcare GmbHSiemens Healthineers

Intracardiac, ultrasound imaging, catheter, steerable, single-use

心内、超声成像、导管、可操纵、一次性使用

Risk class: IV
Applicant: Siemens Medical Solutions USA, Inc.Siemens Medical Solutions Usa , Inc.

Radiographic/Fluoroscopic Units, Mobile

射线照相/透视装置,移动式

Risk class: III
Applicant: Siemens Healthcare GmbHSiemens Healthineers

View all 177 devices →

About this profile

Siemens Healthcare Limited serves as the authorised representative for 177 medical devices in Hong Kong's MDACS framework. Analyse applicant partnerships, risk class exposure, and recent regulatory activity to understand their market footprint.