Philippines FDA registration MDR-10128A

PORTEX® EPIDURAL MINIPACK SYSTEM 1 WITH CLAMP CLEAR CATHETER 3 LATERAL EYES

Name: PORTEX® EPIDURAL MINIPACK SYSTEM 1 WITH CLAMP CLEAR CATHETER 3 LATERAL EYES — Philippines FDA registration MDR-10128A
Creator: Smiths Medical International - Kent, UK Mfd. By: Smiths Medical Czech Republic a.s. - Hranice, Czech Republic For: Smiths Medical ASD, Inc. - 6000 Nathan Lane N., Minneapolis, MN 55442, USA
Keywords: PORTEX® EPIDURAL MINIPACK SYSTEM 1 WITH CLAMP CLEAR CATHETER 3 LATERAL EYES, MDR-10128A, Smiths Medical International - Kent, UK Mfd. By: Smiths Medical Czech Republic a.s. - Hranice, Czech Republic For: Smiths Medical ASD, Inc. - 6000 Nathan Lane N., Minneapolis, MN 55442, USA, Rebmann Inc., USA, Philippines FDA registration

PhilippinesSmiths Medical International - Kent, UK Mfd. By: Smiths Medical Czech Republic a.s. - Hranice, Czech Republic For: Smiths Medical ASD, Inc. - 6000 Nathan Lane N., Minneapolis, MN 55442, USAUSAIssued November 15, 2021 – July 30, 2026

VerifiedFDA Philippines · official registry

Device information

Product Name: PORTEX® EPIDURAL MINIPACK SYSTEM 1 WITH CLAMP CLEAR CATHETER 3 LATERAL EYES
Registration Number: MDR-10128A

Manufacturer details

Manufacturer: Smiths Medical International - Kent, UK Mfd. By: Smiths Medical Czech Republic a.s. - Hranice, Czech Republic For: Smiths Medical ASD, Inc. - 6000 Nathan Lane N., Minneapolis, MN 55442, USA
Country of Origin: USA

Importer & distribution

Importer/Distributor: Rebmann Inc.

Registration dates

Issuance Date: November 15, 2021
Expiry Date: July 30, 2026

About this record

Access comprehensive regulatory information for PORTEX® EPIDURAL MINIPACK SYSTEM 1 WITH CLAMP CLEAR CATHETER 3 LATERAL EYES in the Philippines medical device market through Pure Global AI's free database. This device is registered under FDA registration number MDR-10128A and manufactured by Smiths Medical International - Kent, UK Mfd. By: Smiths Medical Czech Republic a.s. - Hranice, Czech Republic For: Smiths Medical ASD, Inc. - 6000 Nathan Lane N., Minneapolis, MN 55442, USA in USA. The device was registered on November 15, 2021.

This page provides complete registration details including manufacturer information, importer/distributor details (Rebmann Inc.), 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.