Singapore HSA registration DE0016693

Welch Allyn Connex® Vital Signs Monitor 6000 Series™

Singapore·CLASS C·Welch Allyn Inc.·Registered December 26, 2014

Device classification

Device Class: CLASS C
Medical Speciality Area: General Hospital
HSA Product Code: Refer to CRPNS
HS Code: 90181900

Registration information

Registration Number: DE0016693
Registration Date: December 26, 2014
Change Notification Approval Date: June 24, 2022
Retention Due Date: December 25, 2025

Product description

Intended for monitoring of neonatal, pediatric, and adult patients for: • noninvasive blood pressure, • pulse rate, • noninvasive functional oxygen saturation of arteriolar hemoglobin and • body temperature in normal and axillary modes. Model 6300, 6400 and 6500 can be used with Masimo Rainbow SET® indicated for the continuous noninvasive monitoring of total hemoglobin concentration Model 6700 and 6800 can be used with the following modules: Masimo Rainbow® SET Pulse CO-Oximeter™ indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin, pulse rate, total hemoglobin concentration and/or respiration rate.

Product Owner

Name: Welch Allyn Inc.
Short Name: Welch Allyn Inc.
Address: 4341 State Street Road, Skaneateles Falls, NY 13153-0220, UNITED STATES

Registrant

Name: Welch Allyn Singapore Pte. Ltd.
Address: 1 YISHUN AVENUE 7, SINGAPORE 768923

Importer

Name: Gold Lite Pte Ltd WELCH ALLYN SINGAPORE PTE. LTD.
Address: 211 HENDERSON ROAD, HENDERSON INDUSTRIAL PARK, #13-01, SINGAPORE 159552 1 YISHUN AVENUE 7, #00-00, SINGAPORE 768923

Model information

Model Name(s): 008-0834-01 008-0851-00 008-0953-00 01802-110 02894-0000 02894-1000 02895-000 02895-100 05031-101 05031-110 06138-000 104149 104220 104360 104384 104644 104645 104770 104771 104772 104850 4500-30 4500-31 4500-32 4500-925 4700-60 4701-62 4800-60 4900-60 4900-62 5082-101-1 5082-102-1 5082-103-1 5082-104-1 5082-105-1 5200-08 6000-100S 6000-101H 6000-30 6000-31 6000-33 6000-40 6000-50 6000-910 6000-915HS 6000-916 6000-920 ECG Plug-In Module ECG Plug-In Module ECG Plug-In Module ECG Plug-In Module 6000-NC 660-0138-00 660-0320-00 660-0321-00 901060 Vital Signs Monitor 901060 Vital Signs Monitor 901060 Vital Signs Monitor 901060 Vital Signs Monitor 901060 Vital Signs Monitor 901060 Vital Signs Monitor 901060 Vital Signs Monitor 901060 Vital Signs Monitor 901060 Vital Signs Monitor 901060 Vital Signs Monitor 901060 Vital Signs Monitor 901060 Vital Signs Monitor 901060 Vital Signs Monitor 901060 Vital Signs Monitor 901060 Vital Signs Monitor 901060 Vital Signs Monitor 901060 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Vital Signs Monitor 901060 Vital Signs Monitor 901060 Vital Signs Monitor 901060 Vital Signs Monitor 901060 Vital Signs Monitor 901060 Vital Signs Monitor 901060 Vital Signs Monitor 901060 Vital Signs Monitor 901060 Vital Signs Monitor 901060 Vital Signs Monitor 901060 Vital Signs Monitor 901060 Vital Signs Monitor 901060 Vital Signs Monitor 901060 Vital Signs Monitor 901060 Vital Signs Monitor 901060 Vital Signs Monitor 901060 Vital Signs Monitor 901060 Vital Signs Monitor 901060 Vital Signs Monitor 715270 86100 86200 BATT99 D-YS D-YSE D-YSPD DOC-10 DOC-4 DOC-8 DS-100A Inf-Wrap-RP LNC-10 LNC-4 LNCS-ADTX LNCS-DCI LNCS-DCIP LNCS-Inf-3 LNCS-Neo-L-3 LNCS-PDTX LNCS-TC-I LNCS-YI LNOP-ADT LNOP-DCI LNOP-DCIP LNOP-NEO LNOP-NEOPT LNOP-PDT MAX-AI MAX-II MAX-PI Neo-Wrap-RP OXI-A/N OXI-P/I PC-04 PC-08 PWCD-4 RED-LNC-10 Reuse-07-2MQ Reuse-08-2MQ Reuse-09-2MQ Reuse-10-2MQ Reuse-11-2MQ Reuse-11L-2MQ Reuse-12-2MQ Reuse-12L-2MQ Reuse-13-2MQ Soft-07-2MQ Soft-08-2MQ Soft-09-2MQ Soft-10-2MQ Soft-11-2MQ Soft-11L-2MQ Soft-12-2MQ Soft-12L-2MQ Soft-13-2MQ YI-AD YI-FM
Model Identifier(s): 008-0834-01 008-0851-00 008-0953-00 01802-110 02894-0000 02894-1000 02895-000 02895-100 05031-101 05031-110 06138-000 104149 104220 104360 104384 104644 104645 104770 104771 104772 104850 4500-30 4500-31 4500-32 4500-925 4700-60 4701-62 4800-60 4900-60 4900-62 5082-101-1 5082-102-1 5082-103-1 5082-104-1 5082-105-1 5200-08 6000-100S 6000-101H 6000-30 6000-31 6000-33 6000-40 6000-50 6000-910 6000-915HS 6000-916 6000-920 6000-ECG3A 6000-ECG3I 6000-ECG5A 6000-ECG5I 6000-NC 660-0138-00 660-0320-00 660-0321-00 6700 67HREP-4 67HREW-4 67HREX-4 67HREY-4 67HRTP-4 67HRTW-4 67HRTX-4 67HRTY-4 67HRXP-4 67HRXW-4 67HRXX-4 67HRXY-4 67HXEP-4 67HXEW-4 67HXEX-4 67HXEY-4 67HXTP-4 67HXTW-4 67HXTX-4 67HXTY-4 67HXXP-4 67HXXW-4 67HXXX-4 67HXXY-4 67MREP-4 67MREW-4 67MREX-4 67MREY-4 67MRTP-4 67MRTW-4 67MRTX-4 67MRTY-4 67MRXP-4 67MRXW-4 67MRXX-4 67MRXY-4 67MXEP-4 67MXEW-4 67MXEX-4 67MXEY-4 67MXTP-4 67MXTW-4 67MXTX-4 67MXTY-4 67MXXP-4 67MXXW-4 67MXXX-4 67MXXY-4 67NXEP-4 67NXEW-4 67NXEX-4 67NXEY-4 67NXTP-4 67NXTW-4 67NXTX-4 67NXTY-4 67NXXP-4 67NXXW-4 67NXXX-4 67NXXY-4 67XXEP-4 67XXEW-4 67XXEX-4 67XXEY-4 67XXTP-4 67XXTW-4 67XXTX-4 67XXTY-4 67XXXP-4 67XXXW-4 67XXXX-4 67XXXY-4 6800 68HREP-4 68HREW-4 68HREX-4 68HREY-4 68HRTP-4 68HRTW-4 68HRTX-4 68HRTY-4 68HRXP-4 68HRXW-4 68HRXX-4 68HRXY-4 68HXEP-4 68HXEW-4 68HXEX-4 68HXEY-4 68HXTP-4 68HXTW-4 68HXTX-4 68HXTY-4 68HXXP-4 68HXXW-4 68HXXX-4 68HXXY-4 68MREP-4 68MREW-4 68MREX-4 68MREY-4 68MRTP-4 68MRTW-4 68MRTX-4 68MRTY-4 68MRXP-4 68MRXW-4 68MRXX-4 68MRXY-4 68MXEP-4 68MXEW-4 68MXEX-4 68MXEY-4 68MXTP-4 68MXTW-4 68MXTX-4 68MXTY-4 68MXXP-4 68MXXW-4 68MXXX-4 68MXXY-4 68NXEP-4 68NXEW-4 68NXEX-4 68NXEY-4 68NXTP-4 68NXTW-4 68NXTX-4 68NXTY-4 68NXXP-4 68NXXW-4 68NXXX-4 68NXXY-4 68XXEP-4 68XXEW-4 68XXEX-4 68XXEY-4 68XXTP-4 68XXTW-4 68XXTX-4 68XXTY-4 68XXXP-4 68XXXW-4 68XXXX-4 68XXXY-4 715270 86100 86200 BATT99 D-YS D-YSE D-YSPD DOC-10 DOC-4 DOC-8 DS-100A Inf-Wrap-RP LNC-10 LNC-4 LNCS-ADTX LNCS-DCI LNCS-DCIP LNCS-Inf-3 LNCS-Neo-L-3 LNCS-PDTX LNCS-TC-I LNCS-YI LNOP-ADT LNOP-DCI LNOP-DCIP LNOP-NEO LNOP-NEOPT LNOP-PDT MAX-AI MAX-II MAX-PI Neo-Wrap-RP OXI-A/N OXI-P/I PC-04 PC-08 PWCD-4 RED-LNC-10 Reuse-07-2MQ Reuse-08-2MQ Reuse-09-2MQ Reuse-10-2MQ Reuse-11-2MQ Reuse-11L-2MQ Reuse-12-2MQ Reuse-12L-2MQ Reuse-13-2MQ Soft-07-2MQ Soft-08-2MQ Soft-09-2MQ Soft-10-2MQ Soft-11-2MQ Soft-11L-2MQ Soft-12-2MQ Soft-12L-2MQ Soft-13-2MQ YI-AD YI-FM

About this record

Access comprehensive regulatory information for Welch Allyn Connex® Vital Signs Monitor 6000 Series™ in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0016693 and owned by Welch Allyn Inc.. The device was registered on December 26, 2014.

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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