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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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Enema — 7 UDI-DI variants, MDR (Galena Pharma Oy)

MD Atlas
Galena Pharma Oy

Data from EUDAMED, last updated May 23, 2026

Enema

642061571350179BT

7 UDI-DI variants

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

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIb
Manufacturer: Galena Pharma Oy

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Device characteristics

No device characteristics flagged

Identity & classification

Basic UDI-DI: 642061571350179BT
Device name: Enema
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIb
Version date: Nov 13, 2023

Manufacturer & authorised representative

Manufacturer

Name: Galena Pharma Oy
SRN: FI-MF-000000588
Country: Finland
Email: galena@galena.fi

Variants by status

UDI-DI variants

7 UDI-DI variants

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Applied filters

basicUdiUlid01HF4263T8ZCRT9R21KCW2Q4MJ

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

Galax enema 12x5ml06420615710813
Galax enema 2x5ml06420615710790
Galax enema 4x5ml06420615710806
47301106420615710646
47301006420615710639
81233206420615710653
81233406420615710660