Singapore HSA registration DE0503065
Applied Medical Alexis® O Wound 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
- DE0503065
- Registration Date
- May 07, 2019
- Change Notification Approval Date
- January 24, 2025
- Retention Due Date
- May 06, 2026
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.
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
About this record
Access comprehensive regulatory information for Applied Medical Alexis® 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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