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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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Sponges Gauze, non-sterile — 9 UDI-DI variants, MDR (OneMed Group Oy)

MD Atlas
OneMed Group Oy

Data from EUDAMED, last updated May 23, 2026

Sponges Gauze, non-sterile

6438129B0016H9

9 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: OneMed Group Oy

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Device characteristics

No device characteristics flagged

Identity & classification

Basic UDI-DI: 6438129B0016H9
Device name: Sponges Gauze, non-sterile
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Version date: Mar 29, 2022

Manufacturer & authorised representative

Manufacturer

Name: OneMed Group Oy
SRN: FI-MF-000000642
Country: Finland
Email: eudamed.onemedgroup@onemed.com

Variants by status

UDI-DI variants

9 UDI-DI variants

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Applied filters

basicUdiUlid01FZAKHSEZ7RY8AB7PSH0X3M3F

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

evercare Gauze round sponges, diam. 30 mm06438129352290
evercare Gauze round sponges, diam. 70 mm06438129352306
SELEFA® Optimia Flat gauze sponges 30x30 mm06438129154245
SELEFA® Optimia Gauze round sponges, diam. 30 mm06438129354065
SELEFA® Optimia Gauze round sponges, diam. 40 mm06438129354072
SELEFA® Optimia Gauze round sponges, diam. 50 mm06438129354089
SELEFA® Optimia Gauze round sponges, diam. 65 mm06438129354096
SELEFA® Optimia triangular gauze sponges 30 x 30 x 30 mm06438129154115
SELEFA®Optimia Flat gauze sponges 8x8 mm06438129354232