Singapore HSA registration DE0508047
Applied Medical Kii® Dissecting Balloon Access System
Singapore·CLASS B·Applied Medical Resources Corporation·Registered April 27, 2023Device 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 description
The Kii dissecting balloon is indicated for patients undergoing laparoscopic surgery requiring tissue separation of the extraperitoneal space.
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)
- Kii® Dissecting Balloon Access System, Oval Kii® Dissecting Balloon Access System, Round
- Model Identifier(s)
- C0H11 C0H12
About this record
Access comprehensive regulatory information for Applied Medical Kii® 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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B