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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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Balkonik — 2 UDI-DI variants, MDR (Orthoguard Sp. z o.o.)

MD Atlas
Orthoguard Sp. z o.o.

Data from EUDAMED, last updated May 30, 2026

Balkonik

5905957672OG-MO-STPSR

2 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: Orthoguard Sp. z o.o.

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Device characteristics

No device characteristics flagged

Identity & classification

Basic UDI-DI: 5905957672OG-MO-STPSR
Device name: Balkonik
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Version date: Apr 23, 2026

Manufacturer & authorised representative

Manufacturer

Name: Orthoguard Sp. z o.o.
SRN: PL-MF-000050865
Country: Poland
Email: info@orthoguard.pl
Phone: +48664269146

Variants by status

UDI-DI variants

2 UDI-DI variants

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Applied filters

basicUdiUlid01KPXK1FKTHE79Z66RN7XCEDM3

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

OG-MO-STP-ROL-UNI-UN05905957672230
OG-MO-STP-FIX-UNI-UN05905957672223