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B. Braun Cystofix® - HSA Registration DE0018606

Access comprehensive regulatory information for B. Braun Cystofix® in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0018606 and owned by B.Braun Melsungen AG. The device was registered on October 03, 2016.

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
DE0018606
B. Braun Cystofix®
HSA Registration Number: DE0018606
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Product Description

It is intended for catheterisation of the bladder after surgery, in case of bladder dysfunction, urinary retention, for diagnostic purposes, for urine assessment.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0018606
Registration Date
October 03, 2016
Change Notification Approval Date
July 30, 2024
Retention Due Date
October 02, 2025
Product Owner
Short Name
B.Braun
Address
Carl-Braun-straβe 1, 34212 Melsungen, Germany, GERMANY
Registrant
Address
600 NORTH BRIDGE ROAD, PARKVIEW SQUARE, #15-05, SINGAPORE 188778
Importer
Address
600 NORTH BRIDGE ROAD, PARKVIEW SQUARE, #15-05, SINGAPORE 188778
Model Information
Model Name(s)
Cystofix® Minipaed Cystofix® TUR Cystofix® Cystofix® Cystofix® Cystofix® Cystofix® Cystofix® Cystofix® Paed
Model Identifier(s)
4441036 4441354 4450100 4450120 4450130 4450150 4450160 4450170 4450180