Singapore HSA registration DE0509810
Bioretec Activa IM-Nail
Singapore·CLASS D·Bioretec Ltd.·Registered September 18, 2024Device classification
- Device Class
- CLASS D
- Medical Speciality Area
- Orthopaedics
Registration information
- Registration Number
- DE0509810
- Registration Date
- September 18, 2024
- Retention Due Date
- September 17, 2025
Product description
Activa IM-Nail™ is intended for intramedullary nailing of diaphyseal forearm fractures (radius or ulna or both) in pediatric patients in the presence of appropriate immobilization. In diaphyseal forearm fractures the Activa IM-Nail™ is indicated for the patients from 3 years to under 13 years, but the age limits depend on the biological development of the child.
Product Owner
- Name
- Bioretec Ltd.
- Short Name
- Bioretec Ltd.
- Address
- Yrittäjänkulma 5, 33710 Tampere, FINLAND
Registrant
- Address
- 60 PAYA LEBAR ROAD, PAYA LEBAR SQUARE, #07-54, SINGAPORE 409051
Importer
- Address
- 60 PAYA LEBAR ROAD, PAYA LEBAR SQUARE, #07-54, SINGAPORE 409051
Model information
- Model Name(s)
- Activa IM-Nail™ 2.0 x 200mm Activa IM-Nail™ 2.0 x 300mm Activa IM-Nail™ 2.0 x 400mm Activa IM-Nail™ 2.7 x 200mm Activa IM-Nail™ 2.7 x 300mm Activa IM-Nail™ 2.7 x 400mm Activa IM-Nail™ 3.2 x 200mm Activa IM-Nail™ 3.2 x 300mm Activa IM-Nail™ 3.2 x 400mm
- Model Identifier(s)
- B-ANIM-20200 B-ANIM-20300 B-ANIM-20400 B-ANIM-27200 B-ANIM-27300 B-ANIM-27400 B-ANIM-32200 B-ANIM-32300 B-ANIM-32400
About this record
Access comprehensive regulatory information for Bioretec Activa IM-Nail in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0509810 and owned by Bioretec Ltd.. The device was registered on September 18, 2024.
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 D