Philippines FDA registration MDR-07816B

Foley Balloon Catheter (Siliconized) 3-Way

Philippines·Haiyan Kangyuan Medical Instrument Co. Ltd. - Songpodong Road, Shendang Town, 314311 Haiyan, Zhejiang, P.R. China·China·Issued April 23, 2025 – March 14, 2030

Device information

Product Name: Foley Balloon Catheter (Siliconized) 3-Way
Registration Number: MDR-07816B

Manufacturer details

Manufacturer: Haiyan Kangyuan Medical Instrument Co. Ltd. - Songpodong Road, Shendang Town, 314311 Haiyan, Zhejiang, P.R. China
Country of Origin: China

Importer & distribution

Importer/Distributor: AMB HK Enterprises, Inc.

Registration dates

Issuance Date: April 23, 2025
Expiry Date: March 14, 2030

About this record

Access comprehensive regulatory information for Foley Balloon Catheter (Siliconized) 3-Way in the Philippines medical device market through Pure Global AI's free database. This device is registered under FDA registration number MDR-07816B and manufactured by Haiyan Kangyuan Medical Instrument Co. Ltd. - Songpodong Road, Shendang Town, 314311 Haiyan, Zhejiang, P.R. China in China. The device was registered on April 23, 2025.

This page provides complete registration details including manufacturer information, importer/distributor details (AMB HK Enterprises, 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.