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Applied Medical Kiiยฎ Dissecting Balloon Access System - HSA Registration DE0508047

Access comprehensive regulatory information for Applied Medical Kiiยฎ Dissecting Balloon Access System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508047 and owned by Applied Medical Resources Corporation. The device was registered on April 27, 2023.

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
DE0508047
Applied Medical Kiiยฎ Dissecting Balloon Access System
HSA Registration Number: DE0508047
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Product Description

The Kii dissecting balloon is indicated for patients undergoing laparoscopic surgery requiring tissue separation of the extraperitoneal space.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0508047
Registration Date
April 27, 2023
Change Notification Approval Date
January 17, 2025
Retention Due Date
April 26, 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)
Kiiยฎ Dissecting Balloon Access System, Oval Kiiยฎ Dissecting Balloon Access System, Round
Model Identifier(s)
C0H11 C0H12