GUDIDData
eudamed_udi Primary ID: 08594205375305

Respirator Balerina PFHM933 (UDI 08594205375305)

Manufactured by Balerina-Czech, s.r.o.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Respirator Balerina PFHM933 - Primary ID 08594205375305

Device Regulatory Overview

The Respirator Balerina PFHM933 (Model/Catalog Number: 8594205375305) is a medical device manufactured by Balerina-Czech, s.r.o.. This product is indexed under FDA Product Code / Category Classification T020699 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
8594205375305
Product Code / EMDN
T020699
Device Name
Respirator Balerina PFHM933
Database Sync Date
2026-08-09 16:28:56

Full Regulatory Attributes

đź”’ 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 Respirator Balerina PFHM933?

The registered manufacturer of record for Respirator Balerina PFHM933 is Balerina-Czech, s.r.o..

What is the Primary UDI-DI identifier for Respirator Balerina PFHM933?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 08594205375305.

What classification code is assigned to this device?

This device is registered under product classification code T020699.

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