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Edan iM60 Patient Monitor - HSA Registration DE0506071

Access comprehensive regulatory information for Edan iM60 Patient Monitor in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0506071 and owned by Edan Instruments, Inc.. The device was registered on August 16, 2021.

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
DE0506071
Edan iM60 Patient Monitor
HSA Registration Number: DE0506071
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Product Description

The monitors are intended to be used for monitoring, storing, and reviewing of, and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates. The monitors are intended for use by trained healthcare professionals in hospital environments. The iM60 monitor monitors parameters such as ECG (3-lead, 5-lead), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (dual-IBP, NIBP), Cardiac Output (C.O.), Temperature (dual-TEMP) and Expired CO2.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0506071
Registration Date
August 16, 2021
Retention Due Date
August 15, 2025
Product Owner
Short Name
Edan Instruments, Inc.
Address
#15 Jinhui Road, Jinsha Community, Kengzi Sub-District, Pingshan District, 518122 , Shenzhen, CHINA
Registrant
Address
38 JALAN PEMIMPIN, M38, #07-06, SINGAPORE 577178
Importer
Address
38 JALAN PEMIMPIN, M38, #07-06, SINGAPORE 577178
Model Information
Model Name(s)
Adult/Pediatric Airway adapter kit (Respironics 3472ADU-00) Card Slot /Mainstream 6934-00 SpO2 adapter cable, extended (Lemo to DB9) 5-lead, Clip, AHA, Adult/pediatric, Extended 5-lead, Clip, AHA, Adult/pediatric 5-lead, Snap, AHA, Adult/pediatric, Extended 5-lead, Snap, AHA, Adult/pediatric 5-lead, Clip, IEC, Adult/pediatric, Extended 5-lead, Clip, IEC, Adult/pediatric 5-lead, Snap, IEC, Adult/pediatric, Extended 5-lead, Snap, IEC, Adult/pediatric SpO2 adapter cable, standard (Lemo to DB9) In-line Injection temperature probe (BD 684056-SP4042) Respironics CAPNOSTAT 5 EtCO2 (Main-stream) Module 1015928 Temperature Probe Temperature Probe Temperature Probe Temperature Probe Temperature Probe Temperature Probe Temperature Probe Temperature Probe OPC Cuff, Child, range: 12 cm-19 cm OPC Cuff, Small Adult, range: 17 cm-25 cm OPC Cuff, Adult, range: 23 cm-33 cm OPC Cuff, Large Adult, range: 31 cm-40 cm Disposable CO2 Nasal Cannula - Adult (Respironics 3468ADU-00) Disposable CO2 Nasal Cannula - Pediatric (Respironics 3468PED-00) Disposable CO2 Nasal Cannula - Infant (Respironics 3468INF-00) Adult Nasal CO2 with O2 delivery sampling cannula Pediatric Nasal CO2 with O2 delivery sampling cannula Infant Nasal CO2 with O2 delivery sampling cannula Adult/Pediatric Airway adapter kit with dehumidification tubing (Respironics 3473ADU-00) Pediatric/Infant Airway adapter kit with dehumidification tubing (Respironics 3473INF-00) Disposable Sampling Line Kit with Dehumidification Tubing Pediatric mask/mainstream 9960PED-00 Adult standard mask /mainstream 9960STD-00 Adult large mask /mainstream 9960LGE-00 Band/mainstream 8751-00 Adult Nasal/Oral CO2 sampling cannula (Respironics 3470ADU-00) Pediatric Nasal/Oral CO2 sampling cannula (Respironics 3470PED-00) Adult Nasal/Oral CO2 with O2 delivery sampling cannula (Respironics 3471ADU-00) In-line Injection temperature probe housing (BD 680006-SP5045) NIBP Hose, Quick Connect to Quick Connect Reusable Adult/Pediatric Airway Adapter (7007-01) Reusable Neonate/Infant Airway Adapter (7053-01) ECG Electrodes, adult, disposable, 30 pieces ECG Electrodes, child, neo disposable, 50 pieces ECG Electrodes, adult, disposable, 100 pieces NIBP Cuff, neonatal #1, 3 cm-6 cm, disposable NIBP Cuff, neonatal #2, 4 cm-8 cm, disposable NIBP Cuff, neonatal #3, 6 cm-11 cm, disposable NIBP Cuff, neonatal #4, 7 cm-13 cm, disposable NIBP Cuff, neonatal #5, 8 cm-15 cm, disposable 3-lead, 6-pin, Defib-proof, Neonate 3-lead, 12-pin, Defib-proof, Neonate 3-lead, Snap, IEC, Neonate 3-lead, Snap, AHA, Neonate 3-lead, Clip, IEC, Neonate 3-lead, Clip, AHA, Neonate 5-lead, 12-pin, ESU-proof, Adult/pediatric ECG trunk cable, 5-lead, 12-pin, ESU-proof, AHA/IEC, 5.0 m, reusable 5-lead, 12-pin, Defib-proof, Adult/pediatric 5-lead, 12-pin, Defib-proof, Adult/pediatric, Extended 5-lead, 6-pin, ESU-proof, Adult/pediatric 5-lead, 6-pin, ESU-proof, Adult/ pediatric, Extended 5-lead, 6-pin, Defib-proof, Adult/ pediatric 5-lead, 6-pin, Defib-proof, Adult/pediatric, Extended SpO2 Sensor (Single-patient use) SpO2 Sensor (Single-patient use) SpO2 Sensor (Single-patient use) SpO2 Sensor (Single-patient use) CO2 Sampling Line with Male Luer Lock, 2.0 m ECG Conductive Adhesive Electrodes All Purpose Sampling Cannula without filter (Non Sterile). Size: Adult All Purpose Sampling Cannula without filter (Non Sterile). Size: Infant All Purpose Sampling Cannula without filter (Non Sterile). Size: Neonate Duo Flow O2+CO2 Sampling Cannula (Non Sterile). Size: Adult Duo Flow O2+CO2 Sampling Cannula (Non Sterile). Size: Child Capnomask O2+CO2 Sampling Cannula (Non Sterile). Size: Adult Capnomask O2+CO2 Sampling Cannula (Non Sterile). Size: Child NIBP Tube, 3m NIBP Tube, 3m NIBP Cuff, Neonate, 10cm-15cm, reusable NIBP Cuff, Neonate, 6cm-11cm, reusable NIBP Cuff, E5, Infant,10-15cm, reusable NIBP Cuff, E6, Small child,13-17cm, reusable NIBP Cuff, E7, Child,16-21.5cm, reusable NIBP Cuff, E8, Small adult,20.5-28cm, reusable NIBP Cuff, E9, Adult,27-35cm, reusable NIBP Cuff, E10, Large adult,34-43cm, reusable 3-lead, 12-pin, Defib-proof, IEC, Clip 3-lead, 12-pin, Defib-proof, AHA, Clip 3-lead, 12-pin, Defib-proof, IEC, Snap 3-lead, 12-pin, Defib-proof, AHA, Snap 3-lead, 6-pin, Defib-proof, IEC, Clip 3-lead, 6-pin, Defib-proof, AHA, Clip 3-lead, 6-pin, Defib-proof, IEC, Snap 3-lead, 6-pin, Defib-proof, AHA, Snap 3-lead, 12-pin, ESU-proof, IEC, Clip 3-lead, 12-pin, ESU-proof, AHA, Clip 3-lead, 12-pin, ESU-proof, IEC, Snap 3-lead, 12-pin, ESU-proof, AHA, Snap 3-lead, 6-pin, ESU-proof, IEC, Clip 3-lead, 6-pin, ESU-proof, AHA, Clip 3-lead, 6-pin, ESU-proof, IEC, Snap 3-lead, 6-pin, ESU-proof, AHA, Snap 3-lead, Clip, IEC, 1.0m, Reusable ECG limb wires, 3-lead, Snap, IEC, 1.0m, Reusable 3-lead, Clip, AHA, 1.0m, Reusable ECG limb wires, 3-lead, Snap, AHA, 1.0m, Reusable 5-lead, 12-pin, Defib-proof, Clip, IEC, 3.4m, Reusable 5-lead, 12-pin, Defib-proof, Clip, AHA, 3.4m, Reusable 5-lead, 12-pin, Defib-proof, Snap, IEC, 3.4m, Reusable 5-lead, 12-pin, Defib-proof, Snap, AHA, 3.4m, Reusable 5-Lead, 6-pin, Defib-proof, Clip, IEC, 3.4m, Reusable 5-lead, 6-pin, Defib-proof, Clip, AHA, 3.4m, Reusable 5-Lead, 6-pin, Defib-proof, Snap, IEC, 3.4m, Reusable 5-Lead, 6-pin, Defib-proof, Snap, AHA, 3.4m, Reusable 5-lead, 12-pin, ESU-proof, Clip, IEC, 3.4m, Reusable 5-Lead, 12-pin, ESU-proof, Clip, AHA, 3.4m, Reusable 5-Lead, 12-pin, ESU-proof, Snap, IEC, 3.4m, Reusable 5-lead, 12-pin, ESU-proof, Snap, AHA, 3.4m, Reusable 5-lead, 6-pin, ESU-proof, Clip, IEC, 3.4m, Reusable 5-lead, 6-pin, ESU-proof, Clip, AHA, 3.4m, Reusable 5-lead, 6-pin, ESU-proof, Snap, IEC, 3.4m, Reusable 5-lead, 6-pin, ESU-proof, Snap, AHA, 3.4m, Reusable 3-lead, 12-pin, ESU-proof, AHA/IEC, 2.7m, Reusable 3-lead, 12-pin, ESU-proof, AHA/IEC, 5.0m, Reusable 3-lead, 12-pin, Defib-proof, AHA/IEC, 2.7m, Reusable 3-lead, 12-pin, Defib-proof, AHA/IEC, 5.0m, Reusable 3-lead, 6-pin, ESU-proof, AHA/IEC, 2.7m, Reusable 3-lead, 6-pin, ESU-proof, AHA/IEC, 5.0m, Reusable 3-lead, 6-pin, Defib-proof, AHA/IEC, 2.7m, Reusable 3-lead, 6-pin, Defib-proof, AHA/IEC, 5.0m, Reusable APC Cuff, Child (Green), Range: 12 cmโ€“19 cm APC Cuff, Small Adult (Royal Blue), Range: 17 cmโ€“25 cm APC Cuff, Adult (Navy Blue), Range: 23 cmโ€“33 cm APC Cuff, Large Adult (Burgundy), Range: 31 cmโ€“40 cm C.O. cable, 3.0 m Disposable ECG Electrodes Disposable ECG Electrodes Disposable ECG Electrodes Disposable ECG Electrodes Disposable ECG Electrodes Disposable ECG Electrodes CO2 Airway Adapter, Adult, disposable (6063-00) CO2 Airway Adapter, Neonatal (infant/pediatric) (6312-00) Temperature Probe Temperature Probe SpO2 Sensor SpO2 Sensor SpO2 Sensor Dewatering Cup (Single Patient Use, Adult/Pediatric 10 ml) SpO2 Sensor Respironics EtCO2 module/(Side-stream) 1022054 SpO2 Sensor Patient Monitor
Model Identifier(s)
01.12.031598 01.12.078162 01.13.036336 01.13.036620 01.13.036621 01.13.036622 01.13.036623 01.13.036624 01.13.036625 01.13.036626 01.13.036627 01.13.210001 01.13.40119 01.15.040143 01.15.040184 01.15.040185 01.15.040257 01.15.040258 01.15.040420 01.15.040421 01.15.040422 01.15.040423 01.57.000974 01.57.000976 01.57.000977 01.57.000978 01.57.078139 01.57.078140 01.57.078141 01.57.078142 01.57.078143 01.57.078144 01.57.078151 01.57.078152 01.57.078154 01.57.078158 01.57.078159 01.57.078160 01.57.078161 01.57.101019 01.57.101020 01.57.101021 01.57.40120 01.57.471005 01.57.471019 01.57.471020 01.57.471056 01.57.471057 01.57.471060 01.57.471157 01.57.471158 01.57.471159 01.57.471160 01.57.471161 01.57.471193 01.57.471194 01.57.471195 01.57.471196 01.57.471197 01.57.471198 01.57.471226 01.57.471227 01.57.471228 01.57.471229 01.57.471230 01.57.471231 01.57.471232 01.57.471233 01.57.471235 01.57.471236 01.57.471237 01.57.471238 01.57.471275 01.57.471276 01.57.471282 01.57.471283 01.57.471284 01.57.471285 01.57.471286 01.57.471287 01.57.471288 01.57.471291 01.57.471303 01.57.471323 01.57.471324 01.57.471326 01.57.471327 01.57.471328 01.57.471329 01.57.471330 01.57.471331 01.57.471377 01.57.471378 01.57.471379 01.57.471380 01.57.471381 01.57.471382 01.57.471383 01.57.471384 01.57.471385 01.57.471386 01.57.471387 01.57.471388 01.57.471389 01.57.471390 01.57.471391 01.57.471392 01.57.471461 01.57.471462 01.57.471463 01.57.471464 01.57.471465 01.57.471466 01.57.471467 01.57.471468 01.57.471469 01.57.471470 01.57.471471 01.57.471472 01.57.471473 01.57.471474 01.57.471475 01.57.471476 01.57.471477 01.57.471478 01.57.471479 01.57.471480 01.57.471481 01.57.471482 01.57.471483 01.57.471484 01.57.471485 01.57.471486 01.57.471487 01.57.471488 01.57.471494 01.57.471495 01.57.471496 01.57.471497 01.57.471663 01.57.471858 01.57.471859 01.57.471861 01.57.471862 01.57.471897 01.57.471898 01.59.078155 01.59.078156 02.01.110130 02.01.110131 02.01.210119 02.01.210120 02.01.210121 02.01.210520 02.01.210673 02.08.078137 02.57.225000 iM60