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HugeMed Single-use Cystoscope - HSA Registration DE0509260

Access comprehensive regulatory information for HugeMed Single-use Cystoscope in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509260 and owned by Shenzhen HugeMed Medical Technical Development Co., Ltd.. The device was registered on May 07, 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 B
DE0509260
HugeMed Single-use Cystoscope
HSA Registration Number: DE0509260
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Product Description

The single-use cystoscope is a single-use sterile flexible endoscope for endoscopic surgery and examination in lower urinary tract endoscopy. The endoscope is used to provide images by an image processor. The single-use flexible cystoscope is connected to an image processor and used in conjunction with other endoscopic accessories for the purposes of examination and treatment of lower urinary tract in adults, and the endoscope can only be used in a hospital.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0509260
Registration Date
May 07, 2024
Retention Due Date
May 06, 2026
Product Owner
Short Name
Shenzhen HugeMed Medical Technical Development Co., Ltd.
Address
401,501,Building 4, Haizhi Technology Park,Fortis,No 17, Bulan Road,Xialilang Community, Nanwan street Longgang District, CHINA
Registrant
Address
2 ANG MO KIO STREET 64, ECON INDUSTRIAL BUILDING, #05-02A, SINGAPORE 569084
Importer
Address
40 JALAN PEMIMPIN, TAT ANN BUILDING, #03-01C, SINGAPORE 577185
Model Information
Model Name(s)
Single-use Cystoscope Single-use Cystoscope Single-use Cystoscope Single-use Cystoscope Single-use Cystoscope Single-use Cystoscope
Model Identifier(s)
CY-M32 CY-M40 CY-M40H CY-M50 CY-M52 CY-M52H