Philippines FDA registration IVDR-00146

XCEL ONE STEP HCG URINE PREGNANCY TEST CASSETTE

Philippines·Guangzhou Wondfo Biotech Co., Ltd.·China·Issued October 12, 2017 – September 11, 2021

Device information

Product Name: XCEL ONE STEP HCG URINE PREGNANCY TEST CASSETTE
Registration Number: IVDR-00146

Manufacturer details

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Country of Origin: China

Importer & distribution

Importer/Distributor: South East Star Enterprises

Registration dates

Issuance Date: October 12, 2017
Expiry Date: September 11, 2021

About this record

Access comprehensive regulatory information for XCEL ONE STEP HCG URINE PREGNANCY TEST CASSETTE in the Philippines medical device market through Pure Global AI's free database. This device is registered under FDA registration number IVDR-00146 and manufactured by Guangzhou Wondfo Biotech Co., Ltd. in China. The device was registered on October 12, 2017.

This page provides complete registration details including manufacturer information, importer/distributor details (South East Star Enterprises), 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.