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Applied Medical Alexisยฎ O Wound Protector-Retractor - HSA Registration DE0503065

Access comprehensive regulatory information for Applied Medical Alexisยฎ O Wound 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 DE0503065 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
DE0503065
Applied Medical Alexisยฎ O Wound Protector-Retractor
HSA Registration Number: DE0503065
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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 laparoscopic and open surgery. The small and medium Alexis O wound protectors-retractors are capable of temporarily closing an incision to maintain pneumoperitoneum during laparoscopic surgery, or to serve as an additional trocar port site. In addition, indicated sizes may be used to access the thoracic cavity or other soft tissue retraction during cardiac and general surgical procedures.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General & Plastic Surgery
Registration Information
Registration Number
DE0503065
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)
ALEXIS O WND PROT-RET ALEXIS O WND PROT-RET ALEXIS O WND PROT-RET ALEXIS O WND PROT-RET ALEXIS O WND PROT-RET
Model Identifier(s)
C8401 C8402 C8403 C8404 C8405