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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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BALONIX MED (emulsion) — 1 UDI-DI variant, MDD (Fiterman Pharma SRL)

MD Atlas
Fiterman Pharma SRL

Data from EUDAMED, last updated May 30, 2026

BALONIX MED (emulsion)

B-BXMEDEM79

1 UDI-DI variant

MDD [Directive 93/42/EEC on medical devices]Class IIa

Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class IIa
Manufacturer: Fiterman Pharma SRL

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Device characteristics

No device characteristics flagged

Legacy certificates

Certificate number: HD 60149137
Type: refdata.legacy.mdd-certificate-type.ii-excluding-4
Notified body: TUV Rheinland Italia SRL (1936)
Validity: May 26, 2024

Identity & classification

Basic UDI-DI: B-BXMEDEM79
Device name: BALONIX MED (emulsion)
Issuing agency: EUDAMED
Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class IIa
Version date: Mar 14, 2022

Manufacturer & authorised representative

Manufacturer

Name: Fiterman Pharma SRL
SRN: RO-MF-000001410
Country: Romania
Email: ecaterina.jurca@fitermanpharma.ro
Phone: +40232252800

Variants by status

UDI-DI variants

1 UDI-DI variant

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basicUdiUlid01FY45V4E6AK1WE1H9AET7Y9ZR

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

ALINAN COLIC AND BLOATING (emulsion)D-BXMEDEM79