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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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Oxygentherapy mask for tracheostomy — 2 UDI-DI variants, MDR

MD Atlas
FIAB S.p.A.

Data from EUDAMED, last updated May 31, 2026

Oxygentherapy mask for tracheostomy

803300326101000007KD

2 UDI-DI variants

MDR [Regulation (EU) 2017/745 on medical devices]Class IIa

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Manufacturer: FIAB S.p.A.

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Device characteristics

No device characteristics flagged

Identity & classification

Basic UDI-DI: 803300326101000007KD
Device name: —
Device model: Oxygentherapy mask for tracheostomy
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Version date: Dec 22, 2025

Manufacturer & authorised representative

Manufacturer

Name: FIAB S.p.A.
SRN: IT-MF-000005988
Country: Italy
Email: quality@fiab.it
Phone: +39 055 8497943

Variants by status

UDI-DI variants

2 UDI-DI variants

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basicUdiUlid01KD37SCQQAF5QVQKQM6Q4TTET

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

OS/11008033003260463
OS/110P08033003260470