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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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Aerogen Ultra with I-Guard™ Aerosol… — 4 UDI-DI variants, MDR

MD Atlas
Aerogen Ltd

Data from EUDAMED, last updated May 24, 2026

Aerogen Ultra with I-Guard™ Aerosol Mask (Adult)

539151793AG00020WE

4 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: Aerogen Ltd

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Device characteristics

No device characteristics flagged

Identity & classification

Basic UDI-DI: 539151793AG00020WE
Device name: Aerogen Ultra with I-Guard™ Aerosol Mask (Adult)
Device model: AG-AS7001-EUR
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIb
Version date: Apr 20, 2026

Manufacturer & authorised representative

Manufacturer

Name: Aerogen Ltd
SRN: IE-MF-000004597
Country: Ireland
Email: info@aerogen.com
Phone: +353 91 540 400

Variants by status

UDI-DI variants

4 UDI-DI variants

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Applied filters

basicUdiUlid01KPNQ55EWYXGR0TNSGDQNFT8T

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

Aerogen Ultra Starter Kit Adult Mask05391517937909
Aerogen Ultra Starter Kit Ped Mask05391517937916
Aerogen Ultra with I-Guard™ Aerosol Mask (Adult)05391517937886
Aerogen Ultra with I-Guard™ Aerosol Mask (Ped)05391517937893