Welch Allyn® ELI 150c® and ELI 250c®Resting Electrocardiograph - HSA Registration DE0503919
Access comprehensive regulatory information for Welch Allyn® ELI 150c® and ELI 250c®Resting Electrocardiograph in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0503919 and owned by Welch Allyn, Inc.. The device was registered on December 10, 2019.
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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HSA Official Data
CLASS B
DE0503919
Welch Allyn® ELI 150c® and ELI 250c®Resting Electrocardiograph
HSA Registration Number: DE0503919
Product Description
• Device is indicated for use to acquire, analyze, display, and print electrocardiograms. • Device is indicated for use to provide interpretation of the data for consideration by a physician. • Device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis. • The interpretations of ECG offered by the device are only significant when used in conjunction with a physician over-read as well as consideration of all other relevant patient data. • Device is indicated for use on adult and pediatric populations. • The device is not intended to be used as a vital signs physiological monitor.
Device Classification
Device Class
CLASS B
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0503919
Registration Date
December 10, 2019
Change Notification Approval Date
May 28, 2024
Retention Due Date
December 09, 2025
Product Owner
Short Name
Welch Allyn, Inc.
Address
4341 State Street Road, Skaneateles Falls, NY 13153, UNITED STATES
Registrant
Address
1 YISHUN AVENUE 7, SINGAPORE 768923
Importer
Address
211 HENDERSON ROAD, HENDERSON INDUSTRIAL PARK, #13-01, SINGAPORE 159552
1 YISHUN AVENUE 7, #00-00, SINGAPORE 768923
Model Information
Model Name(s)
ELI LINK
ECG MONITORING ELECTRODES CASE 300
ELECTRODE RESTING TAB BOX/500
ELI LINK
Wireless Acquisition Module (WAM) w/o Lead Wires
Wireless Acquisition Module (WAM) w/o Lead Wires INMETRO
TRIGGER MODULE ASSEMBLY
WIRELESS ACQ MOD (WAM) w/ LEADS AHA BANA
WIRELESS ACQ MOD (WAM) w/ LEADS IEC BANA
WIRELESS ACQ MOD (WAM) w/ LEADS AHA CLIP
WIRELESS ACQ MOD (WAM) w/ LEADS IEC CLIP
ACQ MOD (AM12) w/ LEADS AHA BANANA
ACQ MOD (AM12) w/ LEADS IEC BANANA
ACQ MOD (AM12) w/ LEADS AHA CLIP
ACQ MOD (AM12) w/ LEADS IEC CLIP
ULTRA II RESTING TAB ELECTRODES
Thermal Paper
Assurance Paper
Assurance Paper
Thermal Paper
ADAPTER 4mm BAN PLG TO SNAP LDWIRE PK/10
PAT CBL 10WIRE AHA BANANA JSCREW
PAT CBL 10WIRE IEC BANANA JSCREW
PAT CBL 10WIRE AHA SNAP JSCREW
PAT CBL 10WIRE IEC SNAP JSCREW
ECG CABLE RDS TRUNK/YOKE 10 WIRE
ECG CABLE RDS TRUNK/YOKE 13/14 WIRE
ECG CABLE RDS 10 WIRE BANANA AHA
ECG CABLE RDS 10 WIRE BANANA IEC
ECG CABLE RDS 13 WIRE BANANA AHA
ECG CABLE RDS 13 WIRE BANANA IEC
RPLCMNT LEAD SET RDS 10 WIRE BANANA AHA
RPLCMNT LEAD SET RDS 10 WIRE BANANA IEC
REPLACEMENT RDS LIMBS AHA BANANA
REPLACEMENT RDS LIMBS IEC BANANA
REPLACEMENT RDS V1-V3 AHA BANANA
REPLACEMENT RDS C1-C3 IEC BANANA
REPLACEMENT RDS V4-V6 AHA BANANA
REPLACEMENT RDS C4-C6 IEC BANANA
REPLACEMENT RDS V3R V4R V7 BANANA AHA
REPLACEMENT RDS C3R C4R C7 BANANA IEC
REPLACEMENT RDS V7-V9 AHA BANANA
REPLACEMENT RDS C7-C9 IEC BANANA
ECG CABLE RDS 10 WIRE CLIPS AHA
ECG CABLE RDS 10 WIRE CLIPS IEC
RPLCMNT LEAD SET RDS 10 WIRE CLIPS AHA
RPLCMNT LEAD SET RDS 10 WIRE CLIPS IEC
REPLACEMENT RDS LIMBS AHA CLIPS
REPLACEMENT RDS LIMBS IEC CLIPS
REPLACEMENT RDS V1-V3 AHA CLIPS
REPLACEMENT RDS C1-C3 IEC CLIPS
REPLACEMENT RDS V4-V6 AHA CLIPS
REPLACEMENT RDS C4-C6 IEC CLIPS
COMBINER WAM LEADS 10 POS IEC & AHA GRAY
LD SET WAM/AM12 10 WRE AHA BANA GRY
LD SET WAM/AM12 10 WRE IEC BANA GRY
RPLCE LD SET WAM/AM12 LIMBS AHA BANA GRY
RPLCE LD SET WAM/AM12 LIMBS IEC BANA GRY
RPLCE LD SET WAM/AM12 V1-V3 AHA BANA GRY
RPLCE LD SET WAM/AM12 C1-C3 IEC BANA GRY
RPLCE LD SET WAM/AM12 V4-V6 AHA BANA GRY
RPLCE LD SET WAM/AM12 C4-C6 IEC BANA GRY
LD SET AM15E 13 WRE AHA BANA
LD SET AM15E 13 WRE IEC BANA
RPLCE LEAD SET AM15E E2-E4 BANANA AHA GR
RPLCE LEAD SET AM15E E2-E4 BANANA IEC GR
LD SET WAM/AM12 10 WRE AHA CLIP GRY
LD SET WAM/AM12 10 WRE IEC CLIP GRY
RPLCE LD SET WAM/AM12 LIMBS AHA CLIP GRY
RPLCE LD SET WAM/AM12 LIMBS IEC CLIP GRY
RPLCE LD SET WAM/AM12 V1-V3 AHA CLIP GRY
RPLCE LD SET WAM/AM12 C1-C3 IEC CLIP GRY
RPLCE LD SET WAM/AM12 V4-V6 AHA CLIP GRY
RPLCE LD SET WAM/AM12 C4-C6 IEC CLIP GRY
ACQ MOD (AM12) W/O LEAD WIRES
AM12Q W/O PATIENT CABLE
ACQ MOD (AM15E) w/o LEAD WIRES
ACQ MOD (AM12M) w/o LEAD WIRES
Welch Cup Suction Electrodes - Pack of 6
Limb Lead Clamps -Pack of 4
ADAPTER 4mm ELECTRODE CLIP PK/10
CLEAR CHOICE ADAPTER CLIPS PK/10
ELI150c AM12 AHA BAN USB
ELI150c AM12 AHA BAN USB
ELI150c AM12 IEC BAN USB
ELI150c AM12 IEC BAN USB
ELI150c AM12 IEC BAN LAN USBD DICOM
ELI150c AM12 IEC BAN LAN USBD
ELI150c AM12 IEC BAN WLAN USBD
ELI150c AM12 IEC BAN WLAN USBD DICOM
ELI150c AM12 IEC BAN WLAN USBD
ELI150c AM12 IEC BAN USB DICOM
ELI150c AM12 AHA BAN USB
ELI150c WAM AHA BAN WLAN USBD DICOM
ELI150c WAM IEC BAN LAN USBD
WAM INTPR WLAN LAN USBD DICOM XML
ELI150c AM 12 INTPR LAN USBD DICOM
AM-12 INTERPRETIVE USB DEVICE
AM12 UK INTERPRETIVE USB HOST PORT
ELI150c UK IEC AM12 INTPR LAN DICOM
AM 12 UK INTERPRETIVE LAN USBD
AM-12 UK INTPERPRETIVE USB DEVICE
AM 12 INTERPRETVE USB W/LAN & LAN
ELI150c AM 12 INTPR USB HOST PORT
STANDARD AM12 IEC INTERP
ELI150c AM 12 INTPR LAN USB
AM 12 INTPR USB W/LAN & LAN
ELI150c AM 12 NON-INTPR USB HOST PORT
ELI150c AM 12 NON INTPER LAN USBD
AM12 IEC NON-INTERP LAN USBD
AM12 NON INTPR WLAN LAN USBD
ELI150c AM 12 NON-INTPR USB HOST PORT
AM-12 NON INTPR USB DEVICE
ELI150c AM 12 INTPR USB HOST PORT
ELI150c AM 12 INTERPRTV GSM/GPRS & USBD
ELI150c AM 12 NON - INTER LAN & USBD
WAM INTPR USB HOST PORT
ELI150c WAM INTPR USB DEVICE
WAM INTERPRETIVE WLAN LAN USBD
ELI150c WAM INTPR USB HOST PORT
WAM IEC INTERP LAN USBD
ELI150c WAM INTPR LAN USBD
ELI150c WAM INTPR LAN USBD
WAM INTPR WLAN LAN USBD DICOM XML
ELI150c WAM INTPR USBD
ELI150c WAM UK INTPR LAN USBD DICOM
ELI150c WAM INTPR LAN USBD
WAM INTERPRETIVE WLAN LAN USBD
WAM NON-INTERPRETIVE USB HOST PORT
ELI150c WAM UK NON-INT USB HOST PORT
ELI150c WAM LAN USBD
ELI150c WAM NON-INTPR USBD
WAM IEC CLIP INTPR USB HOST
ELI150c WAM INTPR LAN USBD
AM12 UK INTPR USB HOST PORT
RX AM12 UK GSM GPRS (EU) USBD INTPR MS
ELI150c SW v1.21 W/AM12 IEC INT UK
ELI150c SW v1.21 AM 12 INTPR LAN USB
ELI150c AM12 SW 1.21v NONINTPER LAN USBD
SW V1.2.1 W/AM12 IEC NON-INTERP
ELI150c SW V1.21 WAM UK INTPR USB DEVICE
ELI150c SW v1.21 W/WAM IEC INT UK
ELI150c SW v1.21 W/WAM UK IEC
ELI150c SW V1.21 WAM NON INT LAN USBD
RX SW1.21 AM12 INTPR INT-MOD/LAN
ELI250C AM12 AHA BAN LAN USBD
ELI250C AM12 IEC BAN USB
ELI250C WAM AHA BAN LAN USBD
ELI250C WAM AHA BAN LAN USBD
ELI250C WAM IEC BAN USB
AM12 UK NON-INTPR USB HOST PORT
ELI250c AM12 IEC BAN LAN USBD DICOM
ELI250c AM12 IEC BAN LAN USBD DICOM
ELI250C AM12 AHA BAN LAN USBD
ELI250C AM12 IEC BAN USB
AM12 A4 UK INTPR LAN USBD
WAM INTPR W/LAN+LAN USBD DICOM
WAM AHA NON-INTERP
WAM A4 UK INTPR USB HOST PORT
AM12 A4 INTPR USB HOST PORT
Model Identifier(s)
107347
108070
108071
11027-024-50
30012-019-55
30012-019-65
30012-024-51
41000-031-50
41000-031-51
41000-031-52
41000-031-53
41000-032-50
41000-032-51
41000-032-52
41000-032-53
47029
9100-026-50
9100-026-53
9100-026-54
9100-028-50
9281-002-50
9293-032-52
9293-032-53
9293-033-52
9293-033-53
9293-039-50
9293-039-60
9293-040-50
9293-040-51
9293-040-60
9293-040-61
9293-041-50
9293-041-51
9293-041-52
9293-041-53
9293-041-54
9293-041-55
9293-041-56
9293-041-57
9293-041-60
9293-041-61
9293-041-62
9293-041-63
9293-042-50
9293-042-51
9293-043-50
9293-043-51
9293-043-52
9293-043-53
9293-043-54
9293-043-55
9293-043-56
9293-043-57
9293-046-07
9293-046-60
9293-046-61
9293-046-62
9293-046-63
9293-046-64
9293-046-65
9293-046-66
9293-046-67
9293-046-80
9293-046-81
9293-046-82
9293-046-83
9293-047-60
9293-047-61
9293-047-62
9293-047-63
9293-047-64
9293-047-65
9293-047-66
9293-047-67
9293-048-54
9293-062-50
9293-063-50
9293-065-50
9300-036
9300-037
9325-001-50
9325-003-50
ELI150C-AAA-AAAAX
ELI150C-AAA-AAGAX
ELI150C-ACB-AAAAX
ELI150C-ACB-AAABX
ELI150C-ACB-AACBD
ELI150C-ACB-AACBX
ELI150C-ACB-AAGAX
ELI150C-ACB-AAGBD
ELI150C-ACB-AAGBX
ELI150C-ACB-ADAAD
ELI150C-ADA-ADAAX
ELI150C-BCA-ADGBD
ELI150C-BCB-AACAX
ELI150C-BCB-AFGAD
ELI150c-ACB-ABCAD
ELI150c-ACB-ABFAX
ELI150c-ACB-ACAAX
ELI150c-ACB-ACCAD
ELI150c-ACB-ACCAX
ELI150c-ACB-ACFAX
ELI150c-ACB-ACGAB
ELI150c-ACB-ADAAX
ELI150c-ACB-ADCAD
ELI150c-ACB-ADCAX
ELI150c-ACB-ADGAD
ELI150c-ACB-BCAAX
ELI150c-ACB-BCCAX
ELI150c-ACB-BCCBX
ELI150c-ACB-BCGAX
ELI150c-ACB-BDAAX
ELI150c-ACB-BDFAX
ELI150c-ACD-ADAAX
ELI150c-ACD-ADEAX
ELI150c-ACD-BDCAX
ELI150c-BCB-ABAAX
ELI150c-BCB-ABFAX
ELI150c-BCB-ABGAX
ELI150c-BCB-ACAAX
ELI150c-BCB-ACCAD
ELI150c-BCB-ACCAX
ELI150c-BCB-ACCBX
ELI150c-BCB-ACGAD
ELI150c-BCB-ADAAX
ELI150c-BCB-ADCAD
ELI150c-BCB-ADCAX
ELI150c-BCB-ADGAX
ELI150c-BCB-BCAAX
ELI150c-BCB-BDAAX
ELI150c-BCB-BDCAX
ELI150c-BCB-BFAAX
ELI150c-BCD-ADAAX
ELI150c-BCD-ADCAX
ELI150c-CCB-ABAAX
ELI150c-CCB-ADEBB
ELI150c-ECB-ACAAX
ELI150c-ECB-ACCAX
ELI150c-ECB-BCCAX
ELI150c-ECB-BDCAX
ELI150c-FCB-AAFAX
ELI150c-FCB-ACCAX
ELI150c-FCB-ACGAX
ELI150c-FCB-BCCAX
ELI150c-GCD-ADHAX
ELI250C-BCA-AACAX
ELI250C-BCB-AAABX
ELI250C-DCA-AACAX
ELI250C-DCA-AACBX
ELI250C-DCB-AAAAX
ELI250c-ACA-BCAAX
ELI250c-ACB-ADCAD
ELI250c-ACB-ADCBD
ELI250c-BCA-AACBX
ELI250c-BCB-AAAAX
ELI250c-BCB-AACBX
ELI250c-CCB-ACFAD
ELI250c-CCC-BCAAX
ELI250c-DCB-ACABX
ELI250c-FCA-ACABB