eudamed_udi Primary ID: 05900516197469

BOM (UDI 05900516197469)

Manufactured by TORUŃSKIE ZAKŁADY MATERIAŁÓW OPATRUNKOWYCH SPÓŁKA AKCYJNA

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The BOM (Model/Catalog Number: PR-195-MIX1-006) is a medical device manufactured by TORUŃSKIE ZAKŁADY MATERIAŁÓW OPATRUNKOWYCH SPÓŁKA AKCYJNA. This product is indexed under FDA Product Code / Category Classification S010301 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: PR-195-MIX1-006
Product Code / EMDN: S010301
Device Name: MEDICAL PACKAGING
Database Sync Date: 2026-08-09 16:46:51

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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Frequently Asked Questions

Who is the primary manufacturer of BOM?

The registered manufacturer of record for BOM is TORUŃSKIE ZAKŁADY MATERIAŁÓW OPATRUNKOWYCH SPÓŁKA AKCYJNA.

What is the Primary UDI-DI identifier for BOM?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 05900516197469.

What classification code is assigned to this device?

This device is registered under product classification code S010301.

Similar Classification Devices (S010301)

Other Devices by TORUŃSKIE ZAKŁADY MATERIAŁÓW OPATRUNKOWYCH SPÓŁKA AKCYJNA

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