gudid
Primary ID: S3A
CueSee CO-OX (UDI S3A)
Manufactured by Eurotrol B.V.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for CueSee CO-OX - Primary ID S3A
Device Regulatory Overview
The CueSee CO-OX (Model/Catalog Number: S3A) is a medical device manufactured by Eurotrol B.V.. This product is indexed under FDA Product Code / Category Classification GGM within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- S3A
- Product Code / EMDN
- GGM
- Device Name
- CueSee CO-OX S3A is an assayed quality control material for professional use to verify the performance characteristics of the Radiometer ABL800 FLEX series analyzer. CueSee COOX is intended for the quantitative determination of total hemoglobin (tHb), fraction of oxygenated hemoglobin (FO2Hb), fraction of carboxyhemoglobin (FCOHb) and fraction of methemoglobin (FMetHb). CueSee CO-OX is intended for professional users (medical and laboratory personnel) in clinical settings (e.g. hospital or laboratory).
- Database Sync Date
- 2026-08-09 09:26:45
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 CueSee CO-OX?
The registered manufacturer of record for CueSee CO-OX is Eurotrol B.V..
What is the Primary UDI-DI identifier for CueSee CO-OX?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is S3A.
What classification code is assigned to this device?
This device is registered under product classification code GGM.
Similar Classification Devices (GGM)
Other Devices by Eurotrol B.V.
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