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Bain DORA Disposable A.V. Fistula Needle Sets - HSA Registration DE0505617

Access comprehensive regulatory information for Bain DORA Disposable A.V. Fistula Needle Sets in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0505617 and owned by Bain Medical Equipment (Guangzhou) Co., Ltd.. The device was registered on April 06, 2021.

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
DE0505617
Bain DORA Disposable A.V. Fistula Needle Sets
HSA Registration Number: DE0505617
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Product Description

This product is intended to be used as vein puncture for the hemodialysis treatment.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0505617
Registration Date
April 06, 2021
Change Notification Approval Date
August 01, 2022
Retention Due Date
April 05, 2026
Product Owner
Short Name
Bain Medical Equipment (Guangzhou) Co., Ltd.
Address
No. 10, Juncheng Road, Eastern Area, Economic and Technological, Development District, District, Guangzhou, 510760 China, CHINA
Registrant
Address
250 NORTH BRIDGE ROAD, RAFFLES CITY TOWER, #05-01, SINGAPORE 179101
Importer
Address
250 NORTH BRIDGE ROAD, RAFFLES CITY TOWER, #05-01, SINGAPORE 179101
Model Information
Model Name(s)
Disposable A.V. Fistula Needle Set Disposable A.V. Fistula Needle Set Disposable A.V. Fistula Needle Set Disposable A.V. Fistula Needle Set Disposable A.V. Fistula Needle Sets Disposable A.V. Fistula Needle Sets Disposable A.V. Fistula Needle Sets Disposable A.V. Fistula Needle Sets Disposable A.V. Fistula Needle Sets Disposable A.V. Fistula Needle Sets Disposable A.V. Fistula Needle Sets Disposable A.V. Fistula Needle Sets Disposable A.V. Fistula Needle Sets Disposable A.V. Fistula Needle Sets Disposable A.V. Fistula Needle Sets Disposable A.V. Fistula Needle Sets Disposable A.V. Fistula Needle Sets Disposable A.V. Fistula Needle Sets Disposable A.V. Fistula Needle Sets Disposable A.V. Fistula Needle Sets Disposable A.V. Fistula Needle Sets Disposable A.V. Fistula Needle Sets
Model Identifier(s)
BAIN-A.V.F-002 BAIN-A.V.F-006 BAIN-A.V.F-010 BAIN-A.V.F-050 BAIN-A.V.F.-001 BAIN-A.V.F.-001S BAIN-A.V.F.-002S BAIN-A.V.F.-003 BAIN-A.V.F.-003S BAIN-A.V.F.-004 BAIN-A.V.F.-004S BAIN-A.V.F.-005 BAIN-A.V.F.-005S BAIN-A.V.F.-006S BAIN-A.V.F.-007 BAIN-A.V.F.-007S BAIN-A.V.F.-008 BAIN-A.V.F.-008S BAIN-A.V.F.-009S BAIN-A.V.F.-010S BAIN-A.V.F.-011S BAIN-A.V.F.-012S