eudamed_udi
Primary ID: 59051084491488
OPUS mini (UDI 59051084491488)
Manufactured by String Polska Sp. z o.o.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for OPUS mini - Primary ID 59051084491488
Device Regulatory Overview
The OPUS mini (Model/Catalog Number: 12CHECGOPUSM) is a medical device manufactured by String Polska Sp. z o.o.. This product is indexed under FDA Product Code / Category Classification Z12050302 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 12CHECGOPUSM
- Product Code / EMDN
- Z12050302
- Device Name
- Electrocardiograph OPUS mini
- Database Sync Date
- 2026-08-09 18:51:47
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 OPUS mini?
The registered manufacturer of record for OPUS mini is String Polska Sp. z o.o..
What is the Primary UDI-DI identifier for OPUS mini?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 59051084491488.
What classification code is assigned to this device?
This device is registered under product classification code Z12050302.
Similar Classification Devices (Z12050302)
Other Devices by String Polska Sp. z o.o.
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