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GE Corometrics 250cx Series Maternal/Fetal Monitoring System - HSA Registration DE0009005

Access comprehensive regulatory information for GE Corometrics 250cx Series Maternal/Fetal Monitoring System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0009005 and owned by GE Healthcare. The device was registered on April 04, 2012.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS C
DE0009005
GE Corometrics 250cx Series Maternal/Fetal Monitoring System
HSA Registration Number: DE0009005
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Product Description

A Corometrics 250cx Series monitor can be used for routine non-invasive and invasive fetal monitoring throughout labor and delivery. A Corometrics 250cx Series Maternal/Fetal Monitor is intended for monitoring maternal vital signs to help assess maternal well-being. The vital signs which can be measured are summarized below: Blood pressure Pulse Oximetry Heart/Pulse Rate

Device Classification
Device Class
CLASS C
Medical Speciality Area
Obstetrics & Gynaecology
HSA Product Code
Refer to CRPNS
HS Code
90181900
Registration Information
Registration Number
DE0009005
Registration Date
April 04, 2012
Retention Due Date
April 03, 2026
Product Owner
Short Name
GE Healthcare
Address
8200W. Tower Avenue, Milwaukee, Wi 53223, UNITED STATES
Registrant
Address
11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589
Importer
Address
2 Kallang Avene, CT Hub, #05-04, SINGAPORE 339407 11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589 1 MARITIME SQUARE, HARBOURFRONT CENTRE, #13-01, SINGAPORE 099253 1 MARITIME SQUARE, HARBOURFRONT CENTRE, #13-01, SINGAPORE 099253
Model Information
Model Name(s)
Model 146 Fetal Acoustic Stimulator Detachable IEC AC Power Cord, United Kingdom Plug FECG/MECG Adapter Cable MECG Cable for use with detachable leadwires, USA/AHA MECG Cable for use with detachable leadwires, Intl./IEC MECG Cable for use with detachable leadwires (requires 1442AAO), USA/AHA MECG Cable for use with detachable leadwires (requires 1442AAO), Intl./IEC Interface Cable to Nellcor Model N-200/N-400 Pulse Oximetry Monitor, 1-foot Interface Cable to Nellcor Model N-200/M-400 Pulse Oximetry Monitor, 6-foot RS-232C Interface Cable to Quantitative Sentinel/Perinatal System or Trium Legplate for Qwik Connect Plus Spiral Electrode, 8-foot Cord Legplate for Qwik Connect Plus Spiral Electrode, 8-foot Cord Reusable Belt for Button-Style Transducer, Blue Belt Reuse Button Blue 2/pack 100/case ( 1 pink and 1 blue/pack ) Intermediate Cable for Nellcor Sensors 15” Display Medical Grade w/ Filter 15” Display Medical Grade w/ Desk Stand Exergen TAT-5000 Assembly – oC (Only for CORO 250CX) Model 2116B Clinical-Notes/Data-Entry System Button-Style Tocotransducer (Nautilus), 8-foot Cord Loop-Style Tocotransducer (Nautilus), 8-foot Cord Ultrasound Coupling Gel Bottle, 250 ml (12/carton) Attachment Pads for Qwik Connect Plus Spiral Electrode Legplate Ultrasound Coupling Gel Bottle, 5 liter Corometrics™ 250cx Series Monitor Corometrics™ 250cx Series Monitor Model 3116 LDR/LDRP Bedroom Style Mobile CartFinished Model 3116 LDR/LDRP Bedroom Style Mobile CartUnfinished Remote Event Marker Nellcor Durasensor Adult Reusable Finger Probe, NOTE: CE marked by vendor (Nellcor) Multi-Link Snap Leadwires, Set of 5, Individually Detachable, 31 inches Multi-Link Snap Leadwires, Set of 3, Grouped Detachable, 31 inches Multi-Link Grabber Leadwires, Set of 3, Grouped Detachable, 31 inches Leadwire Adapter, 3-Lead Multi-Link to 3-Lead DIN Multi-Link Grabber Leadwires, Set of 5, Individually Detachable, 31 inches NBP Hose Adapter (118-250 Series) Z-Fold Chart Paper Pack, 30240 BPM Heart Rate Scale Z-Fold Chart Paper Pack, 50210 BPM Heart Rate Scale Reusable Belt for Loop-Style Transducer, Mesh Style Reusable Belt for Loop-Style Transducer, Velcro Style Semi-Reusable Belt for Loop-Style Transducer, Velcro Style Reusable Dual-Tube, Threaded-Luer Cuff, Adult, 25-35 cm Range Reusable Single-Tube, Male-Luer Cuff, Adult, 25-35 cm Range Reusable Dual-Tube, Threaded-Luer Cuff, Large Adult, 34-47 cm Range Reusable Single-Tube, Male-Luer Cuff, Large Adult, 33-47 cm Range Reusable Dual-Tube, Threaded-Luer Cuff, Adult Thigh, 46-66 cm Range Reusable Single-Tube, Male-Luer Cuff, Small Adult, 1826 cm Range Button-Style Ultrasound Transducer (Nautilus), 8-foot Cord Button-Style Ultrasound Transducer (Nautilus), 10-foot Cord Loop-Style Ultrasound Transducer (Nautilus), 8-foot Cord Qwik Connect Plus Spiral Electrode Single-Patient Use Belt for Loop-Style Transducer, Foam Style with Velcro Closure Single-Patient Use, Dual-Tube, Locking-Luer Cuff, Large Adult, 33-47 cm Range Single-Patient Use, Dual-Tube, Locking-Luer Cuff, Adult, 25-35 cm Range Single-Patient Use, Dual-Tube, Locking-Luer Cuff, Small Adult, 18-26 cm Range Electrodes, Round, Foam Air Hose for Dual-Tube, Threaded-Luer Cuff, 12-foot Hose Reusable Dual-Tube, Threaded-Luer Cuff, Small Adult Masimo Adult Reusable Finger Probe NOTE: CE marked by vendor (Masimo) D-O, Box of 25 OxyTip+ Adult/Pediatric Sensors D-O sensor
Model Identifier(s)
0146AAY 1392BAU 1442AAO 1553AAO 1553BAO 1554AAO 1554BAO 1557AAO 1557BAO 1558AAO 1590AAO 1591AAO 2015827-001 2015919-001 2025350-001 2028679-002 2028679-006 2036641-002 2116BAX 2264HAX 2264LAX 2434AAO 2464AAO 2475AAO 256CX 259CX 3116AAO 3116BAO 3919BAO 407705-006 411200-001 411203-001 412682-001 414371-001 414556-001 414876-001 4305CAO 4305DAO 4425AAO 4425CAO 4425FAO 5522AAO 5522CAO 5523AAO 5523CAO 5524AAO 5531CAO 5700HAX 5700JAX 5700LAX 7000AAO 8024AAO 900373-001 900373-002 900373-003 9431-004 9461-217 E27795 E9008JC/2002800-001 OXY-AP-25 OXY-F-UN