eudamed_udi
Primary ID: +M582NEMEL0030
NEMEL003 (UDI +M582NEMEL0030)
Manufactured by NorthEast Monitoring, Inc.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for NEMEL003 - Primary ID +M582NEMEL0030
Device Regulatory Overview
The NEMEL003 (Model/Catalog Number: NEMEL003) is a medical device manufactured by NorthEast Monitoring, Inc.. This product is indexed under FDA Product Code / Category Classification C020501 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- NEMEL003
- Product Code / EMDN
- C020501
- Device Name
- NEMEL electrode patch used with the DR400
- Database Sync Date
- 2026-08-09 16:51:49
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 NEMEL003?
The registered manufacturer of record for NEMEL003 is NorthEast Monitoring, Inc..
What is the Primary UDI-DI identifier for NEMEL003?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is +M582NEMEL0030.
What classification code is assigned to this device?
This device is registered under product classification code C020501.
Similar Classification Devices (C020501)
Other Devices by NorthEast Monitoring, Inc.
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