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IntoCare Reusable Powered Handle - HSA Registration DE0508777

Access comprehensive regulatory information for IntoCare Reusable Powered Handle in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508777 and owned by IntoCare Medical Technology (Suzhou) Co., Ltd.. The device was registered on December 20, 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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CLASS B
DE0508777
IntoCare Reusable Powered Handle
HSA Registration Number: DE0508777
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Product Description

The Reusable Powered Handle Universal (Powered Handle for short) is a multi-patient-use, hand-held device, compatible with the following IntoCare disposable staplers: Disposable Circular Stapler, Disposable Linear Stapler, Disposable Linear Cutter, Disposable Linear Cutting Stapler, Disposable Endoscopic Linear Cutter Driving Unit and Reloads.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0508777
Registration Date
December 20, 2023
Retention Due Date
December 19, 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)
IntoCare Reusable Powered Handle
Model Identifier(s)
PHD01A