gudid
Primary ID: 112-00222
iSED Elite (UDI 112-00222)
Manufactured by ALCOR SCIENTIFIC INC.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for iSED Elite - Primary ID 112-00222
Device Regulatory Overview
The iSED Elite (Model/Catalog Number: 112-00222) is a medical device manufactured by ALCOR SCIENTIFIC INC.. This product is indexed under FDA Product Code / Category Classification GKB within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 112-00222
- Product Code / EMDN
- GKB
- Device Name
- Automated Erythrocyte Sedimentation Rate Analyzer
- Database Sync Date
- 2026-08-09 09:37:43
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 iSED Elite?
The registered manufacturer of record for iSED Elite is ALCOR SCIENTIFIC INC..
What is the Primary UDI-DI identifier for iSED Elite?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 112-00222.
What classification code is assigned to this device?
This device is registered under product classification code GKB.
Similar Classification Devices (GKB)
Other Devices by ALCOR SCIENTIFIC INC.
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