Singapore HSA registration DE0506727
WISAP MaxFlator-CO2 Insufflator
Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0506727
- Registration Date
- March 15, 2022
- Retention Due Date
- March 14, 2026
Product description
Device is used for establishing and maintaining a pneumoperitoneum for endoscopic procedures (diagnostic or operative laparoscopy). The Ultra-Low Insufflation Mode of the device enables the indication for pediatric use.
Product Owner
- Short Name
- WISAP Medical Technology GmbH
- Address
- FichtenstraBe 27, 85649 Brunnthal, GERMANY
Registrant
- Address
- 25 INTERNATIONAL BUSINESS PARK, GERMAN CENTRE, #02-61/64, SINGAPORE 609916
Importer
- Address
- 25 INTERNATIONAL BUSINESS PARK, GERMAN CENTRE, #02-55/56, SINGAPORE 609916
Model information
- Model Name(s)
- 45 L/min CO2-Insufflator Heating tube
- Model Identifier(s)
- 1800/45T 7642 HS
About this record
Access comprehensive regulatory information for WISAP MaxFlator-CO2 Insufflator in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0506727 and owned by WISAP Medical Technology GmbH. The device was registered on March 15, 2022.
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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