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Bain NovaHF Hollow Fiber Dialyzer - HSA Registration DE0506737

Access comprehensive regulatory information for Bain NovaHF Hollow Fiber Dialyzer in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0506737 and owned by Bain Medical Equipment (Guangzhou) Co., Ltd.. The device was registered on March 22, 2022.

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 C
DE0506737
Bain NovaHF Hollow Fiber Dialyzer
HSA Registration Number: DE0506737
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Product Description

NovaHF Hollow Fiber Dialyzer can be used for the hemodialysis treatment of acute and chronic renal failure.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Gastroenterology & Urology
Registration Information
Registration Number
DE0506737
Registration Date
March 22, 2022
Change Notification Approval Date
April 18, 2024
Retention Due Date
March 21, 2026
Product Owner
Short Name
Bain Medical Equipment (Guangzhou) Co., Ltd.
Address
No. 10, Juncheng Road, Eastern Area, Economic and Technological, Development District, Guangzhou, 510760, CHINA
Registrant
Address
2 WOODLANDS IND PARK D STREET 2, SINGAPORE 737778
Importer
Address
150 BEACH ROAD, GATEWAY WEST, #30-01/08, SINGAPORE 189720 2 WOODLANDS IND PARK D STREET 2, SINGAPORE 737778
Model Information
Model Name(s)
NovaHF 140 Hollow Fiber Dialyzer NovaHF 160 Hollow Fiber Dialyzer NovaHF 180 Hollow Fiber Dialyzer NovaHF 200 Hollow Fiber Dialyzer NovaHF 220 Hollow Fiber Dialyzer
Model Identifier(s)
B-14HF B-16HF B-18HF B-20HF B-22HF