eudamed_udi
Primary ID: 59044737177464
EM-01 (UDI 59044737177464)
Manufactured by EMTEL Śliwa spółka komandytowa
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for EM-01 - Primary ID 59044737177464
Device Regulatory Overview
The EM-01 (Model/Catalog Number: EM01) is a medical device manufactured by EMTEL Śliwa spółka komandytowa. This product is indexed under FDA Product Code / Category Classification Z12050803 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- EM01
- Product Code / EMDN
- Z12050803
- Device Name
- EM-01 - wireless ECG module
- Database Sync Date
- 2026-08-09 16:49:04
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 EM-01?
The registered manufacturer of record for EM-01 is EMTEL Śliwa spółka komandytowa.
What is the Primary UDI-DI identifier for EM-01?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 59044737177464.
What classification code is assigned to this device?
This device is registered under product classification code Z12050803.
Similar Classification Devices (Z12050803)
Other Devices by EMTEL Śliwa spółka komandytowa
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