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Singapore HSA registration DE0507711

Applied Medical Voyant Electrosurgical Generator System

Singapore flagSingapore·CLASS C·Applied Medical Resources Corporation·Registered January 26, 2023
Device classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0507711
Registration Date
January 26, 2023
Change Notification Approval Date
September 06, 2023
Retention Due Date
January 25, 2026
Product description
The Voyant electrosurgical generator is indicated for use with Voyant devices in open and laparoscopic surgical procedures where the electrosurgical ligation of vessels or tissue bundles is desired. The device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.
Product Owner
Name
Applied Medical Resources Corporation
Short Name
Applied Medical Resources Corporation
Address
22872 Avenida Empresa, Rancho Santa Margarita, California 92688, UNITED STATES
Registrant
Name
APPLIED MEDICAL SINGAPORE PTE. LTD.
Address
600 NORTH BRIDGE ROAD, PARKVIEW SQUARE, #10-01, SINGAPORE 188778
Importer
Name
APPLIED MEDICAL SINGAPORE PTE. LTD.
Address
600 NORTH BRIDGE ROAD, PARKVIEW SQUARE, #10-01, SINGAPORE 188778
Model information
Model Name(s)
Voyant Electrosurgical Generator Voyant 5mm Fusion Device, 5mm x 37cm Voyant 5mm Fusion Device, 5mm x 44cm Voyant Maryland Fusion Device with Single-Step Activation, 5mm x 37cm Voyant Maryland Fusion Device with Single-Step Activation, 5mm x 44cm Voyant Maryland Fusion Device with Single-Step Activation, 5mm x 23cm Voyant Maryland Fusion Device, 5mm x 37cm Voyant Maryland Fusion Device, 5mm x 44cm Voyant Maryland Fusion Device, 5mm x 23cm Voyant Fine Fusion Device Voyant Open Fusion Device
Model Identifier(s)
EA020 EB210 EB211 EB212 EB213 EB214 EB215 EB216 EB217 EB230 EB240
About this record

Access comprehensive regulatory information for Applied Medical Voyant Electrosurgical Generator 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 DE0507711 and owned by Applied Medical Resources Corporation. The device was registered on January 26, 2023.

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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS C