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Summit Dopplers - HSA Registration DE0508529

Access comprehensive regulatory information for Summit Dopplers in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508529 and owned by CooperSurgical, Inc.. The device was registered on September 29, 2023.

This page provides complete registration details including product owner information, registrant details, 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 B
DE0508529
Summit Dopplers
HSA Registration Number: DE0508529
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Product Description

Summit Dopplers will be used to detect blood flow in veins and arteries for assisting in the detection of peripheral vascular disease and to detect fetal heart beats as an aid for determining fetal viability.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0508529
Registration Date
September 29, 2023
Retention Due Date
September 28, 2025
Product Owner
Short Name
CooperSurgical, Inc.
Address
95 Corporate Drive Trumbull,, CT 06611, UNITED STATES
Registrant
Address
50 SERANGOON NORTH AVENUE 4, FIRST CENTRE, #05-14, SINGAPORE 555856
Model Information
Model Name(s)
Gray Coil Cord Doppler Blood pressure pump - aneroid (blood pressure pump) Cuff and Hose Assembly - 1.9cm Digit Cuff and Hose Assembly - 2.5cm Digit Cuff and Hose Assembly - 7.5 cm Metatarsus Cuff and Hose Assembly - 10cm Cuff and Hose Assembly - 10cm - Ankle Left Cuff and Hose Assembly - 10cm - Ankle Right Cuff and Hose Assembly - 12cm Cuff and Hose Assembly -12cm Long Cuff and Hose Assembly - 12cm - Arm Left Cuff and Hose Assembly - 12cm - Arm Right Cuff and Hose Assembly - 17cm Contour Thigh Stereo headphone (all Dopplers) ABI Kit - with aneroid, 2 cuffs, forms, chart, ABI video (not for L250AB/AC or L300AC) ABI 2 cuff package: 10 or 12cm and aneroid (vascular uses) ABI 4 cuff package: 10 or 12cm and aneroid (vascular uses) ABI printer label paper (for ABI systems): 5 rolls with 20 - 30 waveforms per roll ABI Paper (non-adhesive) 5 rolls Thermal printer paper Stand with storage basket for hand-held systems (for L150 and L250) Stand with storage basket for table-top systems (for L350R) Stand without storage basket for hand-held systems (for L150/L250) Stand without storage basket for table-top systems (for L350R) Carrying case for hand-held systems (for L150/L250) Vista AVS Stand (roll-stand with storage basket (for L450VA/L500VA) Vantage ABI Stand (roll-stand with storage basket (for VANABI only) Cuff Selector Vista AVS Wall Mount for Hand Held Doppler Accessory, L350R, Wallmount (Wall mount for table-top Doppler systems) Cuff and Hose Assembly - 17cm, 12 cm Standard - Kit includes (2) CUF0003 Cuffs, (2) CUF0008 Cuffs, and (4) ASY0008 Hoses Summit Doppler™, LifeDop® 250 ABI System with 8 MHz Probe, 2 cuffs aneroid and printer Summit Doppler™, LifeDop® 250 ABI System with 8 MHz Probe, 4 cuffs aneroid and printer Summit Doppler™, LifeDop® 250AR Professional with 2.0 MHz Fetal Probe Summit Doppler™, LifeDop® 250AR Professional with 3.0 MHz Fetal Probe Summit Doppler™, LifeDop® 250AR Professional with 4.0 MHz Vascular Probe Summit Doppler™, LifeDop® 250AR Professional with 5.0 MHz Vascular Probe Summit Doppler™, LifeDop® 250AR Professional with 8.0 MHz Vascular Probe Summit Doppler™, LifeDop® 250AR Professional with 2.0 MHz Waterproof Fetal Probe Summit Doppler™, LifeDop® 250AR Professional with 8.0 MHz Sterilizable Vascular Probe Summit Doppler™, LifeDop® 300 ABI System with 8 MHz Probe, keypad, 4 cuffs aneroid and printer Summit Doppler™, LifeDop® 350R Tabletop Doppler with 2.0 MHz Fetal Probe Summit Doppler™, LifeDop® 350R Tabletop Doppler with 3.0 MHz Fetal Probe Summit Doppler™, LifeDop® 350R Tabletop Doppler with 4.0 MHz Vascular Probe Summit Doppler™, LifeDop® 350R Tabletop Doppler with 5.0 MHz Vascular Probe Summit Doppler™, LifeDop® 350R Tabletop Doppler with 8.0 MHz Vascular Probe Summit Doppler™, LifeDop® 350R Tabletop Doppler with 2.0 MHz Waterproof Fetal Probe Summit Doppler™, Software Package for L450VA Summit Doppler™, Vista™, ABI, Automated ABI System On Screen Guide, PVR, 8 MHz Doppler Probe, Auto Cuff Inflation/Deflation, Stand and 4 Cuffs Summit Doppler™, Vista™ AVS, Advanced ABI/Vascular System On Screen Guide, PVR, 8.0 MHz Doppler Probe, PPG, Auto Cuff Inflation/Deflation, Individual Site Mode, PC Software, Stand and 9 Cuffs ABI report forms - pack of 50 (L250 ABI Systems) Summit Doppler™, Photoplethysmography Probe Recharge adapter (LifeDop 120V) - all rechargeable units Summit Doppler™ • LifeDop® 2.0 MHz Probe Summit Doppler™ • LifeDop® 3.0 MHz Probe Summit Doppler™ • LifeDop® 4.0 MHz Probe Summit Doppler™ • LifeDop® 5.0 MHz Probe Summit Doppler™ • LifeDop® 5.0 MHz Bidirectional Probe Summit Doppler™ • Vista™ 5.0 MHz Bidirectional Probe Summit Doppler™ • LifeDop® 8.0 MHz Probe Summit Doppler™ • LifeDop® 8.0 MHz Bidirectional Probe Summit Doppler™ • Vista™ 8.0 MHz Bidirectional Probe Summit Doppler™ • LifeDop® 2.0 MHz Waterproof Probe Doppler headset with earbud Summit Doppler™, LifeDop® 8.0 MHz Sterilizeable Probe Summit Doppler™, LifeDop® 150 Professional with 8.0 MHz Sterilizable Probe and Rollstand with basket Summit Doppler™, LifeDop® 350R Tabletop Doppler with 8.0 MHz Sterilizable Probe and Rollstand with basket Summit Doppler™ VANMAX Vantage ABI™
Model Identifier(s)
A155 ASY0022 C019 C025 C075 C100 C101 C102 C120 C120L C121 C122 C170 H150 K150 K160 K170 K180 K185 K200 K220 K230 K240 K260 K270 K275 K290 K300 K310 K500VA L250AB L250AC L250AR-SD2 L250AR-SD3 L250AR-SD4 L250AR-SD5 L250AR-SD8 L250AR-SDW L250AR-STN L300AC L350R-SD2 L350R-SD3 L350R-SD4 L350R-SD5 L350R-SD8 L350R-SDW L450SF L450VA L500VA MKT0042 PPG R150 SD2 SD3 SD4 SD5 SD5B SD5V SD8 SD8B SD8V SDW SPK0005 STN STNPK1 STNPK2 VANMAX