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Acon® hCG Pregnancy Rapid Test Cassette - FDA Registration IVDR-00774

Access comprehensive regulatory information for Acon® hCG Pregnancy Rapid Test Cassette in the Philippines medical device market through Pure Global AI's free database. This device is registered under FDA registration number IVDR-00774 and manufactured by Acon Biotech (Hangzhou) Co., Ltd. - No. 210 Zhenzhong Road West Lake District 310030 Hangzhou People's Republic of China in China. The device was registered on June 26, 2025.

This page provides complete registration details including manufacturer information, importer/distributor details (Biosite Medical Instruments), 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.

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IVDR-00774
Acon® hCG Pregnancy Rapid Test Cassette
Registered medical device in Philippines
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Device Information
Product Name
Acon® hCG Pregnancy Rapid Test Cassette
Registration Number
IVDR-00774
Importer & Distribution
Importer/Distributor
Biosite Medical Instruments
Registration Dates
Issuance Date
June 26, 2025
Expiry Date
June 26, 2029