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NIPRO Biohole Buttonhole Device - HSA Registration DE0500134

Access comprehensive regulatory information for NIPRO Biohole Buttonhole Device in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0500134 and owned by NIPRO CORPORATION. The device was registered on September 11, 2013.

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
DE0500134
NIPRO Biohole Buttonhole Device
HSA Registration Number: DE0500134
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Product Description

The Nipro Biohole buttonhole device is used to form a “buttonhole” (a fixed-position puncture tunnel) for connection to hemodialysis equipment and must only be placed and removed by qualified and licensed medical personnel

Device Classification
Device Class
CLASS B
Medical Speciality Area
Gastroenterology & Urology
HSA Product Code
HSAMDB00110
HS Code
90183990
Registration Information
Registration Number
DE0500134
Registration Date
September 11, 2013
Retention Due Date
September 10, 2025
Product Owner
Short Name
NIPRO CORPORATION
Address
3-9-3 Honjo-Nishi, Kita-ku, Osaka, JAPAN
Registrant
Address
6 TEMASEK BOULEVARD, SUNTEC TOWER FOUR, #31-01/02, SINGAPORE 038986
Importer
Address
6 TEMASEK BOULEVARD, SUNTEC TOWER FOUR, #31-01/02, SINGAPORE 038986 10 JOO KOON CRESCENT, SINGAPORE 629012
Model Information
Model Name(s)
NIPRO BioHole
Model Identifier(s)
BHK-165