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Applied Medical Alexisยฎ O C-Section Protector-Retractor - HSA Registration DE0503066

Access comprehensive regulatory information for Applied Medical Alexisยฎ O C-Section Protector-Retractor in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0503066 and owned by Applied Medical Resources Corporation. The device was registered on May 07, 2019.

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.

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CLASS B
DE0503066
Applied Medical Alexisยฎ O C-Section Protector-Retractor
HSA Registration Number: DE0503066
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Product Description

The Alexis O c-section protector-retractor is a device that allows the surgeon to access the abdominal cavity through an atraumatically retracted abdominal incision, providing maximum exposure with minimum incision size. The Alexis O c-section protector-retractor (large and extra large) is indicated for use to assist in non-urgent cesarean deliveries that are routine procedures. It is intended to provide incision retraction and to protect against wound contamination during a cesarean section.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General & Plastic Surgery
Registration Information
Registration Number
DE0503066
Registration Date
May 07, 2019
Change Notification Approval Date
January 24, 2025
Retention Due Date
May 06, 2026
Product Owner
Short Name
Applied Medical Resources Corporation
Address
22872 Avenida Empresa, Rancho Santa Margarita, California 92688, UNITED STATES
Registrant
Address
600 NORTH BRIDGE ROAD, PARKVIEW SQUARE, #10-01, SINGAPORE 188778
Importer
Address
600 NORTH BRIDGE ROAD, PARKVIEW SQUARE, #10-01, SINGAPORE 188778
Model Information
Model Name(s)
Alexisยฎ O C-Section Protector-Retractor Alexisยฎ O C-Section Protector-Retractor
Model Identifier(s)
G6313 G6314