Singapore HSA registration DE0503066
Applied Medical Alexis® O C-Section Protector-Retractor
Singapore·CLASS B·Applied Medical Resources Corporation·Registered May 07, 2019Device 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 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.
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)
- Alexis® O C-Section Protector-Retractor Alexis® O C-Section Protector-Retractor
- Model Identifier(s)
- G6313 G6314
About this record
Access comprehensive regulatory information for Applied Medical Alexis® 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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