Singapore HSA registration DE0508328
Brightwake Hemosep System
Singapore·CLASS C·Brightwake Limited·Registered July 26, 2023Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General & Plastic Surgery
Registration information
- Registration Number
- DE0508328
- Registration Date
- July 26, 2023
- Retention Due Date
- July 25, 2025
Product description
The use of Hemosep for intraoperative cell salvage is recommended in a variety of medium to high blood loss procedures including cardiac, orthopaedic, spinal, renal and vascular surgeries. Hemosep cell salvage may be used in surgical procedures where the surgical field is not contaminated by faecal or infective matter and where no other contraindications exist.
Product Owner
- Short Name
- Brightwake Limited
- Address
- Lowmoor Business Park, Kirkby-in-Ashfield, Nottingham, NG17 7JZ, UNITED KINGDOM
Registrant
- Address
- 10 BUKIT BATOK CRESCENT, THE SPIRE, #07-01, SINGAPORE 658079
Importer
- Address
- 10 BUKIT BATOK CRESCENT, THE SPIRE, #07-01, SINGAPORE 658079
Model information
- Model Name(s)
- Hemosep Shaker Hemosep Cell Concentrator Pack Hemosep Intra-operative Kit Hemosep Suction Kit
- Model Identifier(s)
- CR4213 CR4426 CR4428 CR4434
About this record
Access comprehensive regulatory information for Brightwake Hemosep System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0508328 and owned by Brightwake Limited. The device was registered on July 26, 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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