SC90 (UDI 946-105)
Manufactured by Radiometer Medical ApS
Device Regulatory Overview
The SC90 (Model/Catalog Number: 946-105) is a medical device manufactured by Radiometer Medical ApS. This product is indexed under FDA Product Code / Category Classification GKR within international Unique Device Identification (UDI) compliance databases.
Enforcement actions are currently active for this product line.
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Technical Specifications
- Model Number
- 946-105
- Product Code / EMDN
- GKR
- Device Name
- Sensor cassette SC90 300BG, LYT, MET, OXI + QC for ABL90. 30
- Database Sync Date
- 2026-08-09 09:57:21
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 SC90?
The registered manufacturer of record for SC90 is Radiometer Medical ApS.
What is the Primary UDI-DI identifier for SC90?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 946-105.
What classification code is assigned to this device?
This device is registered under product classification code GKR.
Similar Classification Devices (GKR)
Other Devices by Radiometer Medical ApS
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