gudid
Primary ID: 60-01-9002
DZ-Lite c270 (UDI 60-01-9002)
Manufactured by TOKYO BOEKI MEDISYS INC.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for DZ-Lite c270 - Primary ID 60-01-9002
Device Regulatory Overview
The DZ-Lite c270 (Model/Catalog Number: 60-01-9002) is a medical device manufactured by TOKYO BOEKI MEDISYS INC.. This product is indexed under FDA Product Code / Category Classification JJE within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 60-01-9002
- Product Code / EMDN
- JJE
- Device Name
- DZ-Lite c270 is discrete photometric clinical chemistry analyzer. The device is intended to duplicate manual analytical procedures by automating various steps such as pipetting, heating, measuring color intensity, and reporting results. The device is intended to be used with certain materials to measure various analytes of diagnostic interest including glucose. An optional Ion Selective Electrode Module is intended to measure sodium, potassium and chloride. DZ-Lite c270 with glucose hexokinase assay are intended to measure glucose quantitatively in human serum. Additionally, DZ-Lite c270 with Ion-Selective Elective modules additionally measure the concentration of the electrolytes, sodium, potassium and chloride in serum, using indirect potentiometry.
- Database Sync Date
- 2026-08-09 09:15:37
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 DZ-Lite c270?
The registered manufacturer of record for DZ-Lite c270 is TOKYO BOEKI MEDISYS INC..
What is the Primary UDI-DI identifier for DZ-Lite c270?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 60-01-9002.
What classification code is assigned to this device?
This device is registered under product classification code JJE.
Similar Classification Devices (JJE)
Other Devices by TOKYO BOEKI MEDISYS INC.
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