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Singapore HSA registration DE0502386

Applied Medical GelPOINT Path Transanal Access Platform

Singapore flagSingapore·CLASS B·Applied Medical Resources Corporation·Registered November 29, 2018
Device classification
Device Class
CLASS B
Medical Speciality Area
Gastroenterology & Urology
Registration information
Registration Number
DE0502386
Registration Date
November 29, 2018
Change Notification Approval Date
January 13, 2025
Retention Due Date
November 28, 2025
Product description
The GelPOINT Path Transanal Access Platform is indicated for multiple instrument or camera access through the anus for the performance of various diagnostic and therapeutic procedures using additional instruments.
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 Path Transanal Access Platform GelPOINT Path Transanal Access Platform GelPOINT Path Transanal Access Platform
Model Identifier(s)
CNB10 CNB11 CNB12
About this record

Access comprehensive regulatory information for Applied Medical GelPOINT Path Transanal 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 DE0502386 and owned by Applied Medical Resources Corporation. The device was registered on November 29, 2018.

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