gudid
Primary ID: OLO-U1
Sight OLO (UDI OLO-U1)
Manufactured by S.D. SIGHT DIAGNOSTICS LTD
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Sight OLO - Primary ID OLO-U1
Device Regulatory Overview
The Sight OLO (Model/Catalog Number: OLO-U1) is a medical device manufactured by S.D. SIGHT DIAGNOSTICS LTD. This product is indexed under FDA Product Code / Category Classification GKZ within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- OLO-U1
- Product Code / EMDN
- GKZ
- Device Name
- The Sight OLO device is a computer vision based platform for blood analysis. The platform combines computer-vision algorithms for image processing to identify and quantify blood components (e.g., red blood cells) and their characteristics (e.g., cell volume) in an automated fashion.
- Database Sync Date
- 2026-08-09 09:06:27
Full Regulatory Attributes
🔒 Token Gated
{
"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 Sight OLO?
The registered manufacturer of record for Sight OLO is S.D. SIGHT DIAGNOSTICS LTD.
What is the Primary UDI-DI identifier for Sight OLO?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is OLO-U1.
What classification code is assigned to this device?
This device is registered under product classification code GKZ.
Similar Classification Devices (GKZ)
Other Devices by S.D. SIGHT DIAGNOSTICS LTD
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