Philippines FDA registration MDR-09818

FMS® FLUID MANAGEMENT SYSTEM OUTFLOW TUBING WITH ONE-WAY VALVE

Name: FMS® FLUID MANAGEMENT SYSTEM OUTFLOW TUBING WITH ONE-WAY VALVE — Philippines FDA registration MDR-09818
Creator: Depuy Mitek, Inc. - Raynham, Massachusetts, USA mfd. By: Harmac Medical Products, Inc. H3 de Tijuana S.de RL de CVF - Nueva, Tijuana CP Mexico
Keywords: FMS® FLUID MANAGEMENT SYSTEM OUTFLOW TUBING WITH ONE-WAY VALVE, MDR-09818, Depuy Mitek, Inc. - Raynham, Massachusetts, USA mfd. By: Harmac Medical Products, Inc. H3 de Tijuana S.de RL de CVF - Nueva, Tijuana CP Mexico, Johnson & Johnson (Phils), Inc., Mexico, Philippines FDA registration

PhilippinesDepuy Mitek, Inc. - Raynham, Massachusetts, USA mfd. By: Harmac Medical Products, Inc. H3 de Tijuana S.de RL de CVF - Nueva, Tijuana CP MexicoMexicoIssued October 21, 2021 – June 15, 2026

VerifiedFDA Philippines · official registry

Device information

Product Name: FMS® FLUID MANAGEMENT SYSTEM OUTFLOW TUBING WITH ONE-WAY VALVE
Registration Number: MDR-09818

Manufacturer details

Manufacturer: Depuy Mitek, Inc. - Raynham, Massachusetts, USA mfd. By: Harmac Medical Products, Inc. H3 de Tijuana S.de RL de CVF - Nueva, Tijuana CP Mexico
Country of Origin: Mexico

Importer & distribution

Importer/Distributor: Johnson & Johnson (Phils), Inc.

Registration dates

Issuance Date: October 21, 2021
Expiry Date: June 15, 2026

About this record

Access comprehensive regulatory information for FMS® FLUID MANAGEMENT SYSTEM OUTFLOW TUBING WITH ONE-WAY VALVE in the Philippines medical device market through Pure Global AI's free database. This device is registered under FDA registration number MDR-09818 and manufactured by Depuy Mitek, Inc. - Raynham, Massachusetts, USA mfd. By: Harmac Medical Products, Inc. H3 de Tijuana S.de RL de CVF - Nueva, Tijuana CP Mexico in Mexico. The device was registered on October 21, 2021.

This page provides complete registration details including manufacturer information, importer/distributor details (Johnson & Johnson (Phils), 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.