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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Respirator Balerina PFHM931 — 104 UDI-DI variants, MDR

MD Atlas
Balerina-Czech, s.r.o.

Data from EUDAMED, last updated May 23, 2026

Respirator Balerina PFHM931

859420537PFHM931R8

104 UDI-DI variants

MDR [Regulation (EU) 2017/745 on medical devices]Class I

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Manufacturer: Balerina-Czech, s.r.o.

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Device characteristics

No device characteristics flagged

Identity & classification

Basic UDI-DI: 859420537PFHM931R8
Device name: Respirator Balerina PFHM931
Device model: PFHM931
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Version date: Jan 12, 2026

Manufacturer & authorised representative

Manufacturer

Name: Balerina-Czech, s.r.o.
SRN: CZ-MF-000050806
Country: Czechia
Email: info@balerina.cz

Variants by status

UDI-DI variants

104 UDI-DI variants

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Applied filters

basicUdiUlid01KERR11KD09C0KZDZ96EB8XXA

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

No registered UDI-DI variants for this device family.