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IntoCare IntoCare Disposable Powered Circular Stapler - HSA Registration DE0509396

Access comprehensive regulatory information for IntoCare IntoCare Disposable Powered Circular Stapler in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0509396 and owned by IntoCare Medical Technology (Suzhou) Co., Ltd.. The device was registered on June 13, 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.

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CLASS C
DE0509396
IntoCare IntoCare Disposable Powered Circular Stapler
HSA Registration Number: DE0509396
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Product Description

The IntoCareโ„ข Powered Stapler is intended to be used for the creation of anastomoses. It may also be used during open surgery or endoscopic surgery. The device is intended to mechanically cut the tissue and simultaneously apply surgical staples to the resulting perimeter of the cutting line. Details as: Disposable Powered Circular Stapler: Powered Handle used with Disposable Circular Stapler has application throughout the alimentary tract for end-to-end and end-to-side anastomoses. These instruments are suitable for open or minimally invasive general surgery, which can be used together with staple line or tissue support materials.

Device Classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0509396
Registration Date
June 13, 2024
Retention Due Date
June 12, 2025
Product Owner
Short Name
IntoCare Medical Technology (Suzhou) Co., Ltd.
Address
Unit 102/202/301/302/402, East Building 6, No.9 West Suhong Road, Suzhou Industrial Park, Pilot Free Trade Zone Suzhou Area, 215000 Jiangsu, CHINA
Registrant
Address
65 UBI ROAD 1, OXLEY BIZHUB, #04-30, SINGAPORE 408729
Importer
Address
65 UBI ROAD 1, OXLEY BIZHUB, #04-30, SINGAPORE 408729
Model Information
Model Name(s)
Disposable Powered Circular Stapler Disposable Powered Circular Stapler Disposable Powered Circular Stapler Disposable Powered Circular Stapler Disposable Powered Circular Stapler Disposable Powered Circular Stapler Disposable Powered Circular Stapler Disposable Powered Circular Stapler Disposable Powered Circular Stapler Disposable Powered Circular Stapler Disposable Powered Circular Stapler Disposable Powered Circular Stapler Disposable Powered Circular Stapler Disposable Powered Circular Stapler Disposable Powered Circular Stapler Single Use Powered Handle, Universal
Model Identifier(s)
ICS21 ICS21L ICS25 ICS25L ICS29 ICS29L ICS31 ICS31L ICS33 ICS33L ISC21 ISC25 ISC29 ISC31 ISC33 PHDS01A