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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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Hyper-Box System, Australia — 1 UDI-DI variant, MDD (AOTI Limited)

MD Atlas
AOTI Limited

Data from EUDAMED, last updated May 31, 2026

Hyper-Box System, Australia

B-05391518741031

1 UDI-DI variant

MDD [Directive 93/42/EEC on medical devices]Class IIa

Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class IIa
Manufacturer: AOTI Limited

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Device characteristics

Active deviceAdministers medicine

Legacy certificates

Certificate number: 252.728
Type: refdata.legacy.mdd-certificate-type.v
Notified body: National Standards Authority of Ireland (NSAI) (0050)
Validity: May 26, 2024

Identity & classification

Basic UDI-DI: B-05391518741031
Device name: Hyper-Box System, Australia
Device model: Hyper-Box System
Issuing agency: EUDAMED
Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class IIa
Version date: May 26, 2026

Manufacturer & authorised representative

Manufacturer

Name: AOTI Limited
SRN: IE-MF-000025075
Country: Ireland
Email: robbie.walsh@aotinc.net
Phone: +353872355402

Variants by status

UDI-DI variants

1 UDI-DI variant

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Applied filters

basicUdiUlid01KSJGSMSAS8PXHM8JE7FN1CQA

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

Hyper-Box System, Australia05391518741031