Philippines FDA registration CMDR-2025-04453B

Omni Legend PET/CT System

Philippines·GE Medical System LLC 3000 N. Grandview Blvd. Waukesha, WI 53188 USA Mfd by: GE Hualun Medical Systems Co., Ltd. - No. 1 Yong Chang·USA·Issued May 07, 2025 – May 07, 2030

Device information

Product Name: Omni Legend PET/CT System
Registration Number: CMDR-2025-04453B

Manufacturer details

Manufacturer: GE Medical System LLC 3000 N. Grandview Blvd. Waukesha, WI 53188 USA Mfd by: GE Hualun Medical Systems Co., Ltd. - No. 1 Yong Chang
Country of Origin: USA

Importer & distribution

Importer/Distributor: General Electric Philippines, Inc.

Registration dates

Issuance Date: May 07, 2025
Expiry Date: May 07, 2030

About this record

Access comprehensive regulatory information for Omni Legend PET/CT System in the Philippines medical device market through Pure Global AI's free database. This device is registered under FDA registration number CMDR-2025-04453B and manufactured by GE Medical System LLC 3000 N. Grandview Blvd. Waukesha, WI 53188 USA Mfd by: GE Hualun Medical Systems Co., Ltd. - No. 1 Yong Chang in USA. The device was registered on May 07, 2025.

This page provides complete registration details including manufacturer information, importer/distributor details (General Electric Philippines, 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.