Digital Electrocardiograph (UDI iE 12A)
Manufactured by Shenzhen Biocare Bio-Medical Equipment Co., Ltd.
Device Regulatory Overview
The Digital Electrocardiograph (Model/Catalog Number: iE 12A) is a medical device manufactured by Shenzhen Biocare Bio-Medical Equipment Co., Ltd.. This product is indexed under FDA Product Code / Category Classification DPS within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- iE 12A
- Product Code / EMDN
- DPS
- Device Name
- Database Sync Date
- 2026-08-09 09:04:56
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 Digital Electrocardiograph?
The registered manufacturer of record for Digital Electrocardiograph is Shenzhen Biocare Bio-Medical Equipment Co., Ltd..
What is the Primary UDI-DI identifier for Digital Electrocardiograph?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is iE 12A.
What classification code is assigned to this device?
This device is registered under product classification code DPS.
Similar Classification Devices (DPS)
Other Devices by Shenzhen Biocare Bio-Medical Equipment Co., Ltd.
Programmatic Export
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JSON API Endpoint