gudid
Primary ID: SE-1010
PC ECG (UDI SE-1010)
Manufactured by Edan Instruments, Inc.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for PC ECG - Primary ID SE-1010
Device Regulatory Overview
The PC ECG (Model/Catalog Number: SE-1010) is a medical device manufactured by Edan Instruments, Inc.. This product is indexed under FDA Product Code / Category Classification DPS within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- SE-1010
- Product Code / EMDN
- DPS
- Device Name
- Database Sync Date
- 2026-08-09 09:11:06
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 PC ECG?
The registered manufacturer of record for PC ECG is Edan Instruments, Inc..
What is the Primary UDI-DI identifier for PC ECG?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is SE-1010.
What classification code is assigned to this device?
This device is registered under product classification code DPS.
Similar Classification Devices (DPS)
Other Devices by Edan Instruments, Inc.
Programmatic Export
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JSON API Endpoint