Singapore HSA registration DE0507910

Fresenius Medical Care Fresline Extra-Corporeal Blood Circuit

Singapore·CLASS B·Fresenius Medical Care Singapore Pte Ltd.·Registered March 16, 2023

Device classification

Device Class: CLASS B
Medical Speciality Area: General Hospital

Registration information

Registration Number: DE0507910
Registration Date: March 16, 2023
Retention Due Date: March 15, 2026

Product description

Fresline Extracorporeal Blood Circuit acts as extracorporeal blood channel during blood purification treatment.

Product Owner

Name: Fresenius Medical Care Singapore Pte Ltd.
Short Name: Fresenius Medical Care Singapore Pte Ltd.
Address: 250 NORTH BRIDGE ROAD, RAFFLES CITY TOWER, #05-01, SINGAPORE 179101

Registrant

Name: FRESENIUS MEDICAL CARE SINGAPORE PTE. LTD.
Address: 250 NORTH BRIDGE ROAD, RAFFLES CITY TOWER, #05-01, SINGAPORE 179101

Importer

Name: FRESENIUS KABI (SINGAPORE) PTE LTD FRESENIUS MEDICAL CARE SINGAPORE PTE. LTD.
Address: 238A THOMSON ROAD, NOVENA SQUARE, #24-03/05, SINGAPORE 307684 250 NORTH BRIDGE ROAD, RAFFLES CITY TOWER, #05-01, SINGAPORE 179101

Model information

Model Name(s): Fresline Extra-corporeal blood circuit Fresline Extra-corporeal blood circuit Fresline Extra-corporeal blood circuit Fresline Extra-corporeal blood circuit Fresline Extra-corporeal blood circuit Fresline Extra-corporeal blood circuit Fresline Extra-corporeal blood circuit Fresline Extra-corporeal blood circuit Fresline Extra-corporeal blood circuit Fresline Extra-corporeal blood circuit
Model Identifier(s): TX-HA-17 TX-HA-18 TX-HB-19 TX-JB-10 TX-JB-12 TX-JC-7 TX-KA-13 TX-KA-14 TX-KB-15 TX-KB-16

About this record

Access comprehensive regulatory information for Fresenius Medical Care Fresline Extra-Corporeal Blood Circuit in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0507910 and owned by Fresenius Medical Care Singapore Pte Ltd.. The device was registered on March 16, 2023.

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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