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Applied Medical Alexis® Orthopaedic Protector - HSA Registration DE0503064

Access comprehensive regulatory information for Applied Medical Alexis® Orthopaedic Protector in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0503064 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
DE0503064
Applied Medical Alexis® Orthopaedic Protector
HSA Registration Number: DE0503064
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Product Description

The Alexis Orthopaedic Protector is indicated for use to access the musculoskeletal system through an a traumatically retracted wound.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General & Plastic Surgery
Registration Information
Registration Number
DE0503064
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 ORTHOPAEDIC PROTECTOR S/S 2.5-8cm Alexis ORTHOPAEDIC PROTECTOR S/M 2.5-8cm Alexis ORTHOPAEDIC PROTECTOR M/L 5-13cm
Model Identifier(s)
HR001 HR004 HR005