Medical Device Division · registration 190273Active

GE

Name: GE — Medical Device Division 190273
Creator: GE Medical Systems (China) Co., Ltd.
Keywords: GE, GE, 190273, Scanning Systems, Ultrasonic, Cardiac, Medical Device Division

Hong KongScanning Systems, Ultrasonic, CardiacClass IIGE Medical Systems (China) Co., Ltd.

Verified

Official record identity

MDACS listing number: 190273
Model name: Vivid T8, Vivid T9, M5Sc-RS (H44901AG), 3SC-RS (H45041DL), 6S-RS (H45021RP), 12S-RS (H44901AB), 9L-RS (H40442LL), 12L-RS (H40402LY), L6-12-RS (H48062AC), L4-20t-RS (H48062AJ), 4C-RS (H4000SR), 8C-RS(H40402LS), C1-5-RS (H40462LA), E8Cs-RS (H48062AF), E8Cs-RS (H40402LN), 6Tc-RS (H45551ZE), 9T-RS (H45541YM), P2D (H45551CA), L8-18i-RS (H40462LF), ML6-15-RS (H40462LM), Bite Hole Indicator (H45531HS), TEE Storage rack (H45551NM), TEE Clip-On Bite Guard Adult (H45511EE), TEE Clip-On Bite Guard Adult OR (H45521CB), TEE Conventional Bite Guard Pediatric (H45521JG), TEE Conventional Bite Guard Adult (H45521JH), Adult TEE Scanhead Protection Cover (H45521CK), Pediatric TEE Scanhead Protection Cover (H45541RN), change to AdvVascular to include BFI/Bfflow/BFIAngio (H48432AS), AutoEF 3.0 (H48572BR), Smart Stress (H48432AT), AFI 3.0 (H48572BP), LOGIQ View (H48442AN), Ultrasound DICOM viewer (H48532BS), AdvQScan(TSI, SI, SRI) (H48912AS), AFI RV (H45601TT), AFI LA (H45601TU), AI AUto Measure -2D (H45601YX), AI Auto Measure - Spectrum Recongnition (H45601YY), Streaming(alton HCAT) (H45601GJ), Vascular Contrast (H48932BM), Pre/Post Compare (H48932BK), Easy Auto EF (H48082BK), Easy AFI LV (H48082BL), Probe Check (H45611MS), LVO Contrast (H48442AJ), Advanced Contrast (H4932BL), Enable M5Sc probe (H48532BW), Clarity+ (Advanced SRI) (H48232DW), Remote Viewing (H45611MR), Vivid T-Series v208 eDelivery (H48362DKED), Vivid T8T9 v208 physical SE USB (H48092BY), ECG cable adult AHA GE (H45601SB), ECG lead set adult AHA GE (H45601SC), ECG cable adult IEC GE (H45601SD), ECG lead set adult IEC GE (H45601SE), External ECG Cable (H45021LL), Lead electr neo AHA 600 (H45571RJ), ECG cable neo AHA GE (H45601SF), Lead electr neo IEC 600 (H45571RK), ECG cable neo IEC GE (H45601SG), GE DIN Converter 3-Lead (H45601SK), 3SP Multi-angle Biopsy (H46222LC), L6-12-RS BIOPSY GUIDE (H40432LC), 12L TRANSVERSE BRACKET (H48392LL), INFINITE 12L BIOPSY KIT (H48392LT), 9L BIO GUIDE STARTER KIT (H4906BK), ML6-15 Biopsy Starter Kit (H40432LJ), M5Sc-RS Biopsy Kit (H45561FC), L4-20t Verza biopsy starter kit (H45201BLF), 4C BIOPSY BRACKET (E8385NA), C1-5 Biopsy Starter Kit (H40432LE), E8C REUSABLE BIOPSY KIT (H40412LN), E721 STARTER KIT / biopsy kit for E8C-SC (E8385MJ)
Registration date: February 11, 2025
Expiry date: September 02, 2029
Source update date: February 12, 2025
Status: Active

Classification

Risk class: Class II
Published category: Scanning Systems, Ultrasonic, Cardiac

Published parties

Registrant / registration holder: GE Medical Systems Hong Kong Limited
Manufacturer: GE Medical Systems (China) Co., Ltd.

Official description

Scanning Systems, Ultrasonic, Cardiac

Additional source fields

AMD nomenclature code: 17422
Local responsible person phone: 21006300
Published manufacturer address: No. 19, Changjiang Road, Wuxi National Hi-Tech Dev. Zone, 214028 Jiangsu, China
Revision number: b

About this record

This page mirrors one official MDACS listing. Roman-numeral classes use Hong Kong’s general medical-device scheme, while letter classes use the IVD scheme. Valid, expired, and delisted records remain distinguishable; no mixed classification scale is fabricated.