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Philippines FDA registration CMDR-2025-04676

Bistos Pulse Oximeter

PhilippinesBistos Co., Ltd. - 7th Fl., A Bldg., Woolim Lions Valley 5-cha, 302, Galmachi-ro, Jungwon-gu, Seongnam-si, Gyeonggi-do, Republic of KoreaSouth KoreaIssued June 13, 2025 – June 13, 2030
VerifiedFDA Philippines · official registry
Device information
Product Name
Bistos Pulse Oximeter
Registration Number
CMDR-2025-04676
Manufacturer details
Manufacturer
Bistos Co., Ltd. - 7th Fl., A Bldg., Woolim Lions Valley 5-cha, 302, Galmachi-ro, Jungwon-gu, Seongnam-si, Gyeonggi-do, Republic of Korea
Country of Origin
South Korea
Importer & distribution
Importer/Distributor
Sunfu Solutions, Inc.
Registration dates
Issuance Date
June 13, 2025
Expiry Date
June 13, 2030
About this record

Access comprehensive regulatory information for Bistos Pulse Oximeter in the Philippines medical device market through Pure Global AI's free database. This device is registered under FDA registration number CMDR-2025-04676 and manufactured by Bistos Co., Ltd. - 7th Fl., A Bldg., Woolim Lions Valley 5-cha, 302, Galmachi-ro, Jungwon-gu, Seongnam-si, Gyeonggi-do, Republic of Korea in South Korea. The device was registered on June 13, 2025.

This page provides complete registration details including manufacturer information, importer/distributor details (Sunfu Solutions, 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.