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Shenzhen HugeMed Single-use Bronchoscope - HSA Registration DE0509644

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 DE0509644 and owned by Shenzhen HugeMed Medical Technical Development Co., Ltd.. The device was registered on August 08, 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
DE0509644
Shenzhen HugeMed Single-use Bronchoscope
HSA Registration Number: DE0509644
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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 is indicated for use in a hospital, and for the treatment of adults.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Ear, Nose & Throat
Registration Information
Registration Number
DE0509644
Registration Date
August 08, 2024
Retention Due Date
August 07, 2025
Product Owner
Short Name
Shenzhen HugeMed Medical Technical Development Co., Ltd.
Address
415, 416-1,516-1 Building 2, No.1 Mawu Road, Baoan Community, Yuanshan Street, Longgang District, 518115, Shenzhen, Guangdong, CHINA
Registrant
Address
10 BUKIT BATOK CRESCENT, THE SPIRE, #07-01, SINGAPORE 658079
Importer
Address
10 BUKIT BATOK CRESCENT, THE SPIRE, #07-01, SINGAPORE 658079
Model Information
Model Name(s)
Single-use Bronchoscope Single-use Bronchoscope Single-use Bronchoscope Single-use Bronchoscope Single-use Bronchoscope Single-use Bronchoscope
Model Identifier(s)
BR-M22 BR-M32 BR-M40 BR-M50 BR-M52 BR-M58