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Applied Medical Alexis Laproscopic system with Kii Fios First Entry - HSA Registration DE0502421

Access comprehensive regulatory information for Applied Medical Alexis Laproscopic system with Kii Fios First Entry in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0502421 and owned by Applied Medical Resources Corporation. The device was registered on December 11, 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.

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CLASS B
DE0502421
Applied Medical Alexis Laproscopic system with Kii Fios First Entry
HSA Registration Number: DE0502421
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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 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 trocar.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0502421
Registration Date
December 11, 2018
Change Notification Approval Date
June 10, 2024
Retention Due Date
December 10, 2025
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 Laproscopic system with Kii Fios First Entry Alexis Laproscopic system with Kii Fios First Entry
Model Identifier(s)
C8701 C8702