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Singapore HSA registration DE0506800

Applied Medical GelPOINT V-Path Transvaginal Access Platform

Singapore flagSingapore·CLASS B·Applied Medical Resources Corporation·Registered April 18, 2022
Device classification
Device Class
CLASS B
Medical Speciality Area
Obstetrics & Gynaecology
Registration information
Registration Number
DE0506800
Registration Date
April 18, 2022
Change Notification Approval Date
September 12, 2024
Retention Due Date
April 17, 2026
Product description
The GelPOINT V-Path Transvaginal Access Platform is intended to be inserted transvaginally to establish a path of entry for minimally invasive instruments while maintaining insufflation during laparoscopic-assisted and vaginal gynecological procedures. The device is also a conduit for the extraction of specimens.
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)
GelPOINT V-Path Transvaginal Access Platform, 11cm inner ring diameter GelPOINT V-Path Transvaginal Access Platform, 9.5cm inner ring diameter GelPOINT V-Path Transvaginal Access Platform, 7cm inner ring diameter
Model Identifier(s)
C2A11 C2A12 C2A15
About this record

Access comprehensive regulatory information for Applied Medical GelPOINT V-Path Transvaginal Access Platform in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0506800 and owned by Applied Medical Resources Corporation. The device was registered on April 18, 2022.

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 B