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GE Corometrics Models 171/172 System - HSA Registration DE0007606

Access comprehensive regulatory information for GE Corometrics Models 171/172 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 DE0007606 and owned by GE Medical Systems Information Technologies, Inc.. The device was registered on September 21, 2011.

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
DE0007606
GE Corometrics Models 171/172 System
HSA Registration Number: DE0007606
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Product Description

Models 171 and 172 Fetal Monitors are indicated for use: in antepartum testing of fetal well-being, particularly in the high-risk pregnancy; and for routine noninvasive monitoring throughout labor and delivery.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Obstetrics & Gynaecology
HSA Product Code
Refer to CRPNS
HS Code
90181900
Registration Information
Registration Number
DE0007606
Registration Date
September 21, 2011
Retention Due Date
September 20, 2025
Product Owner
Short Name
GE Medical Systems
Address
8200 W. Tower Ave., Milwaukee, WI, 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 Interface Cable Generic RS-232 Corometrics 171 Corometrics 172 Reusable Belt for Button-Style Transducer, Blue (10/carton)ย ย ย  BELT REUSE BUTTON BLUE 2/PACK 100/CASE ( 1 pink and 1 blue/pack ) (100 packs/case) Button-Style Tocotransducer (Nautilus), 8-foot Cord Loop-Style Tocotransducer (Nautilus), 8-foot Cord Ultrasound Coupling Gel Bottle, 250 ml (12/carton) Ultrasound Coupling Gel Bottle, 5 liter Model 3116 LDR/LDRP Bedroom Style Mobile CartFinished Model 3116 LDR/LDRP Bedroom Style Mobile CartUnfinished Remote Event Marker Z-Fold Chart Paper Pack, 30240 BPM Heart Rate Scale (40/carton) Z-Fold Chart Paper Pack, 50210 BPM Heart Rate Scale (40/carton) Reusable Belt for Loop-Style Transducer, Mesh Style (10/carton) Reusable Belt for Loop-Style Transducer, Velcro Style (10/carton) Semi-Reusable Belt for Loop-Style Transducer, Velcro Style (2/pack; 50 packs/carton) Button-Style Ultrasound Transducer (Nautilus), 8-foot Cord Button-Style Ultrasound Transducer (Nautilus), 10-foot Cord Loop-Style Ultrasound Transducer (Nautilus), 8-foot Cord Single-Patient Use Belt for Loop-Style Transducer, Foam Style with Velcro Closure
Model Identifier(s)
0146AAY 1416AAO 2000268-196 2000269-197 2015827-001 2015919-001 2264HAX 2264LAX 2434AAO 2475AAO 3116AAO 3116BAO 3919BAO 4305CAO 4305DAO 4425AAO 4425CAO 4425FAO 5700HAX 5700JAX 5700LAX 8024AAO