GUDIDData
eudamed_udi Primary ID: 05900516500344

BOM (UDI 05900516500344)

Manufactured by TORUŃSKIE ZAKŁADY MATERIAŁÓW OPATRUNKOWYCH SPÓŁKA AKCYJNA

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for BOM - Primary ID 05900516500344

Device Regulatory Overview

The BOM (Model/Catalog Number: OM-191-FPPA-108) is a medical device manufactured by TORUŃSKIE ZAKŁADY MATERIAŁÓW OPATRUNKOWYCH SPÓŁKA AKCYJNA. This product is indexed under FDA Product Code / Category Classification S01010101 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
OM-191-FPPA-108
Product Code / EMDN
S01010101
Device Name
MEDICAL PACKAGING
Database Sync Date
2026-08-09 16:28:44

Full Regulatory Attributes

🔒 Token Gated
{
    "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 05900516500344.

What classification code is assigned to this device?

This device is registered under product classification code S01010101.

Similar Classification Devices (S01010101)

Other Devices by TORUŃSKIE ZAKŁADY MATERIAŁÓW OPATRUNKOWYCH SPÓŁKA AKCYJNA

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