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Shenzhen HugeMed Single-use Bronchoscope - HSA Registration DE0510598

Access comprehensive regulatory information for Shenzhen HugeMed Single-use Bronchoscope in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510598 and owned by Shenzhen HugeMed Medical Technical Development Co., Ltd.. The device was registered on April 15, 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.

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CLASS B
DE0510598
Shenzhen HugeMed Single-use Bronchoscope
HSA Registration Number: DE0510598
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Product Description

The product is a single-use sterile flexible endoscope for endoscopic surgery and examination in the anatomy of nasal cavity and upper respiratory tract. The endoscope is used to provide images through an endoscopy video processor manufactured by HugeMed. The single-use flexible bronchoscope is connected to an endoscopy video processor manufactured by HugeMed, and used in conjunction with other endoscopic accessories for the examination and treatment of trachea and bronchus in adults. The endoscope in indicated for use in a hospital, and for the treatment of adults.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Gastroenterology & Urology
Registration Information
Registration Number
DE0510598
Registration Date
April 15, 2025
Retention Due Date
April 14, 2026
Product Owner
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
Address
300 Tampines Avenue 5, #09-02, SINGAPORE 529653
Model Information
Model Name(s)
Single-use Bronchoscope Single-use Bronchoscope Single-use Bronchoscope Single-use Bronchoscope Single-use Bronchoscope Single-use Bronchoscope Single-use Bronchoscope Single-use Bronchoscope Single-use Bronchoscope Single-use Bronchoscope
Model Identifier(s)
BR-M22 BR-M25 BR-M32 BR-M40 BR-M40H BR-M50 BR-M52 BR-M52H BR-M58 BR-M58H