eudamed_udi
Primary ID: 08800065178001
CERA-STAT™ HbA1c Control Solution (UDI 08800065178001)
Manufactured by GC MEDIS Corp.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for CERA-STAT™ HbA1c Control Solution - Primary ID 08800065178001
Device Regulatory Overview
The CERA-STAT™ HbA1c Control Solution (Model/Catalog Number: CS400C10) is a medical device manufactured by GC MEDIS Corp.. This product is indexed under FDA Product Code / Category Classification W0101050205 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- CS400C10
- Product Code / EMDN
- W0101050205
- Device Name
- CERA-STAT™ HbA1c Control Solution
- Database Sync Date
- 2026-08-09 18:09:58
Full Regulatory Attributes
🔒 Token Gated
{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
Unlock Compliance Data & Serialization Specs
Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.
Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of CERA-STAT™ HbA1c Control Solution?
The registered manufacturer of record for CERA-STAT™ HbA1c Control Solution is GC MEDIS Corp..
What is the Primary UDI-DI identifier for CERA-STAT™ HbA1c Control Solution?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 08800065178001.
What classification code is assigned to this device?
This device is registered under product classification code W0101050205.
Similar Classification Devices (W0101050205)
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint