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Singapore HSA registration DE0508618

Applied Medical Alexis Laparoscopic System

Singapore flagSingapore·CLASS B·Applied Medical Resources Corporation·Registered October 31, 2023
Device classification
Device Class
CLASS B
Medical Speciality Area
General & Plastic Surgery
Registration information
Registration Number
DE0508618
Registration Date
October 31, 2023
Change Notification Approval Date
January 31, 2025
Retention Due Date
October 30, 2025
Product description
The Alexis O wound protector-retractor is a device that allows the surgeon to access the abdominal cavity through an atraumatically retracted wound, providing maximum exposure with minimum incision size. In addition to incision retraction, it is intended to protect against wound contamination during both open and laparoscopic surgery. The Alexis O wound protector-retractor may be used to access the thoracic cavity or other soft tissue retraction during cardiac and general surgical procedures. The laparoscopic cap is intended to be used during laparoscopic surgery to seal the retracted wound or to convert the retracted wound site into an additional trocar port for 12mm trocars.
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
DKSH SINGAPORE PTE. LTD.
Address
47 JALAN BUROH, #09-01, SINGAPORE 619491
Model information
Model Name(s)
C8501, S ALEXIS LAP SYS 6/BX C8502, M ALEXIS LAP SYS 6/BX
Model Identifier(s)
C8501 C8502
About this record

Access comprehensive regulatory information for Applied Medical Alexis Laparoscopic System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508618 and owned by Applied Medical Resources Corporation. The device was registered on October 31, 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 B