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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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Surgical Face Mask Antifog, non-sterile — 2 UDI-DI variants, MDR

MD Atlas
OneMed Group Oy

Data from EUDAMED, last updated May 23, 2026

Surgical Face Mask Antifog, non-sterile

6438129B0046HJ

2 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: 6438129B0046HJ
Device name: Surgical Face Mask Antifog, 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

2 UDI-DI variants

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Applied filters

basicUdiUlid01FZAKHRPG0G8XD6M11HF43Y44

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

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evercare® Medical Face Mask Type IIR, tie-band, antifog, eye shield, antireflection, blue06438129325089