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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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Swabs Gauze, folded, non-sterile — 18 UDI-DI variants, MDR

MD Atlas
OneMed Group Oy

Data from EUDAMED, last updated May 23, 2026

Swabs Gauze, folded, non-sterile

6438129B0015H7

18 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: 6438129B0015H7
Device name: Swabs Gauze, folded, 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

18 UDI-DI variants

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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 Gauze swabs 10 x 20 cm, 12-ply, non-sterile06438129351866
SELEFA Gauze swabs 10x10 cm, 12-ply, non-sterile06438129351859
SELEFA Gauze swabs 10x10 cm, 8-ply, non-sterile06438129352276
SELEFA Gauze swabs 10x20 cm, 8-ply, non-sterile06438129352283
SELEFA Gauze swabs 5 x 5 cm, 12-ply, non-sterile06438129351835
SELEFA Gauze swabs 5x5 cm, 8-ply, non-sterile06438129352252
SELEFA Gauze swabs 7,5x7,5 cm, 12-ply, non-sterile06438129351842
SELEFA Gauze swabs 7,5x7,5 cm, 8-ply, non-sterile06438129352269
SELEFA® Optimia Gauze squares 15 x 15 cm06438129354188
SELEFA® Optimia Gauze squares 20 x 20 cm06438129354195
SELEFA® Optimia Gauze squares 30 x 30 cm06438129354201
SELEFA® Optimia Gauze squares 40 x 40 cm06438129354218
SELEFA® Optimia Gauze squares 50 x 50 cm06438129354225
SELEFA® Optimia Gauze swabs 10 x 10 cm, 16-ply06438129353969
SELEFA® Optimia Gauze swabs 10 x 10 cm, 8-ply06438129353945
SELEFA® Optimia Gauze swabs 10 x 20 cm, 12-ply06438129353952
SELEFA® Optimia Gauze swabs 7,5 x 7,5 cm, 8-ply06438129353938
SELEFA®Optimia Gauze swabs 5 x 5 cm, 8-ply06438129353921