Singapore HSA registration DE0018704
Schiller 24/48 Hour Ambulatory Blood Pressure Recorder
Singapore·CLASS B·Schiller AG·Registered November 04, 2016Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0018704
- Registration Date
- November 04, 2016
- Change Notification Approval Date
- June 18, 2021
- Retention Due Date
- November 03, 2025
Product description
The SCHILLER BR-102 plus / BR-102 plus PWA is a non-invasive ambulatory blood pressure recorder. It uses auscultatoric and oscillometric signals, or purely oscillometric signals to measure the blood pressure of human beings. Systolic, diastolic, mean arterial pressure and heart rate are measured. The BR-102 plus, BR-102 plus PWA is intended as an aid to diagnosis and treatment when it is necessary to measure an adult or adolescent patient's blood pressure over an extended period of time (up to 48 hours). It can be used for Adults and children of both sexes and all races. The BR-102 plus/ BR-102 plus PWA should not be used with neonates and children under age of 3.
Product Owner
- Name
- Schiller AG
- Short Name
- Schiller AG
- Address
- Altgasse 68, CH-6341 Baar, SWITZERLAND
Registrant
- Address
- 196 PANDAN LOOP, PANTECH BUSINESS HUB, #04-29, SINGAPORE 128384
Importer
- Address
- 211 HENDERSON ROAD, HENDERSON INDUSTRIAL PARK, #13-01, SINGAPORE 159552 211 HENDERSON ROAD, 211 HENDERSON, #13-01, SINGAPORE 159552
Model information
- Model Name(s)
- BR-102 plus BR-102 Plus PWA CD for DARWIN2 ABPM software Works on PC with Windows 7 (32 or 64bit) BP cuff with bow 2014 size M (oscillometric measurement method) BP cuff with bow 2014 size M (auscultatory and oscillometric measurement BP cuff 2014 size S Darwin 2 - Update from Darwin Darwin 2 - Office Software Darwin 2 - Professional Software Darwin 2 - Enterprise Software Darwin 2 - HL7/SAP/BAPI connection Software Darwin 2 - Office Starter Darwin 2 - Professional Starter Darwin 2 - Enterprise Starter Darwin 2 - HRV
- Model Identifier(s)
- 0.293000 0.294000 2.100295 2.120061 2.120062 2.120064 5.281012 5.281030 5.281031 5.281032 5.281034 5.281100 5.281110 5.281120 5.281130
About this record
Access comprehensive regulatory information for Schiller 24/48 Hour Ambulatory Blood Pressure Recorder in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0018704 and owned by Schiller AG. The device was registered on November 04, 2016.
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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