gudid
Primary ID: H9200
Hemo-QC (UDI H9200)
Manufactured by HEMO BIOSCIENCE INC
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Hemo-QC - Primary ID H9200
Device Regulatory Overview
The Hemo-QC (Model/Catalog Number: H9200) is a medical device manufactured by HEMO BIOSCIENCE INC. This product is indexed under FDA Product Code / Category Classification KSF within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- H9200
- Product Code / EMDN
- KSF
- Device Name
- Hemo-QC simulates blood samples and is intended for the daily quality control of routine blood bank reagents used in manual, semi-automated and automated blood typing and antibody screen test systems.
- Database Sync Date
- 2026-08-09 09:49:26
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 Hemo-QC?
The registered manufacturer of record for Hemo-QC is HEMO BIOSCIENCE INC.
What is the Primary UDI-DI identifier for Hemo-QC?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is H9200.
What classification code is assigned to this device?
This device is registered under product classification code KSF.
Similar Classification Devices (KSF)
Other Devices by HEMO BIOSCIENCE INC
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