Philippines FDA registration MDR-00294

TUTA CYSTOSCOPY / BLADDER SET

Name: TUTA CYSTOSCOPY / BLADDER SET — Philippines FDA registration MDR-00294
Creator: ICU Medical Australia Pty. Ltd. Unit 10-16 South St., Ryadalmere, NSW 2141 Australia Mfd By: Amsino Medical (Shanghai) Co., Ltd. - Building #1-3, 16, Lane 355, Huazhe Road, Songjiang Export, Processing Zone, 201613 Shanghai, People's Republic of China
Keywords: TUTA CYSTOSCOPY / BLADDER SET, MDR-00294, ICU Medical Australia Pty. Ltd. Unit 10-16 South St., Ryadalmere, NSW 2141 Australia Mfd By: Amsino Medical (Shanghai) Co., Ltd. - Building #1-3, 16, Lane 355, Huazhe Road, Songjiang Export, Processing Zone, 201613 Shanghai, People's Republic of China, East Lane Corporation, China, Philippines FDA registration

PhilippinesICU Medical Australia Pty. Ltd. Unit 10-16 South St., Ryadalmere, NSW 2141 Australia Mfd By: Amsino Medical (Shanghai) Co., Ltd. - Building #1-3, 16, Lane 355, Huazhe Road, Songjiang Export, Processing Zone, 201613 Shanghai, People's Republic of ChinaChinaIssued May 09, 2024 – December 21, 2028

VerifiedFDA Philippines · official registry

Device information

Product Name: TUTA CYSTOSCOPY / BLADDER SET
Registration Number: MDR-00294

Manufacturer details

Manufacturer: ICU Medical Australia Pty. Ltd. Unit 10-16 South St., Ryadalmere, NSW 2141 Australia Mfd By: Amsino Medical (Shanghai) Co., Ltd. - Building #1-3, 16, Lane 355, Huazhe Road, Songjiang Export, Processing Zone, 201613 Shanghai, People's Republic of China
Country of Origin: China

Importer & distribution

Importer/Distributor: East Lane Corporation

Registration dates

Issuance Date: May 09, 2024
Expiry Date: December 21, 2028

About this record

Access comprehensive regulatory information for TUTA CYSTOSCOPY / BLADDER SET in the Philippines medical device market through Pure Global AI's free database. This device is registered under FDA registration number MDR-00294 and manufactured by ICU Medical Australia Pty. Ltd. Unit 10-16 South St., Ryadalmere, NSW 2141 Australia Mfd By: Amsino Medical (Shanghai) Co., Ltd. - Building #1-3, 16, Lane 355, Huazhe Road, Songjiang Export, Processing Zone, 201613 Shanghai, People's Republic of China in China. The device was registered on May 09, 2024.

This page provides complete registration details including manufacturer information, importer/distributor details (East Lane Corporation), and regulatory compliance data from the official Philippines FDA medical device database. Pure Global AI offers free access to Philippines' complete medical device registry, helping global MedTech companies navigate FDA regulations efficiently.