eudamed_udi
Primary ID: 06975447581037
Galaxy Pro (UDI 06975447581037)
Manufactured by Igenesis(Shanghai)Co.,Ltd.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Galaxy Pro - Primary ID 06975447581037
Device Regulatory Overview
The Galaxy Pro (Model/Catalog Number: 101-0037-01) is a medical device manufactured by Igenesis(Shanghai)Co.,Ltd.. This product is indexed under FDA Product Code / Category Classification W02050116 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 101-0037-01
- Product Code / EMDN
- W02050116
- Device Name
- Automated Fully Enclosed qPCR Instrument
- Database Sync Date
- 2026-08-09 16:51:46
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of Galaxy Pro?
The registered manufacturer of record for Galaxy Pro is Igenesis(Shanghai)Co.,Ltd..
What is the Primary UDI-DI identifier for Galaxy Pro?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06975447581037.
What classification code is assigned to this device?
This device is registered under product classification code W02050116.
Similar Classification Devices (W02050116)
Other Devices by Igenesis(Shanghai)Co.,Ltd.
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