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Singapore HSA registration DE0510285

Shenzhen HugeMed Single-use Cystoscope

Singapore flagSingapore·CLASS B·Shenzhen HugeMed Medical Technical Development Co., Ltd.·Registered January 27, 2025
Device classification
Device Class
CLASS B
Medical Speciality Area
Gastroenterology & Urology
Registration information
Registration Number
DE0510285
Registration Date
January 27, 2025
Retention Due Date
January 26, 2026
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.
Product Owner
Name
Shenzhen HugeMed Medical Technical Development Co., Ltd.
Short Name
Shenzhen HugeMed Medical Technical Development Co., Ltd.
Address
401,501,Bldg 4, Haizhi Tech Park, Fortis, No. 17, Bulan Road, Xialilang Community, Nanwan Street, Longgang District, Shenzhen, Guangdong, 518112, CHINA
Registrant
Name
ANDAMAN MEDICAL PTE. LTD.
Address
300 Tampines Avenue 5, #09-02, SINGAPORE 529653
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
About this record

Access comprehensive regulatory information for Shenzhen 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 DE0510285 and owned by Shenzhen HugeMed Medical Technical Development Co., Ltd.. The device was registered on January 27, 2025.

This page provides complete registration details including product owner information, registrant details, 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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B