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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, sterile — 6 UDI-DI variants, MDR (OneMed Group Oy)

MD Atlas
OneMed Group Oy

Data from EUDAMED, last updated May 23, 2026

Sponges Gauze, sterile

6438129B0018HD

6 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: 6438129B0018HD
Device name: Sponges Gauze, sterile
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Version date: Oct 26, 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

6 UDI-DI variants

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Applied filters

basicUdiUlid01GGA2RAX61BC5DD9EVTE0XYP2

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

SELEFA® Flat gauze sponges, 5-pack, sterile06438129154252
SELEFA® Gauze round sponges, diam. 30 mm, 5-pack, sterile06438129151138
SELEFA® Gauze round sponges, diam. 40 mm, 5-pack, sterile06438129151145
SELEFA® Gauze round sponges, diam. 50 mm, 5-pack, sterile06438129151152
SELEFA® Gauze round sponges, diam. 70 mm, 5-pack, sterile06438129151374
SELEFA® Triangular gauze sponges 30 x 30 x 30 mm, sterile06438129154108