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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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Organization name
UDI-DI code
Reference / catalog number

Hyper-Box System, Belgium — Class IIa MDD by AOTI Limited

MD Atlas
AOTI Limited

EUDAMED last updated this device on Mar 27, 2026

Hyper-Box System, Belgium

B-05391518740997

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: AOTI Limited
UDI-DI code: 05391518740997
Reference / catalog number: G00001-2-BEL

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Manufacturer information

Organization name: AOTI Limited
SRN: IE-MF-000025075
Manufacturer status: Active

Related devices

Hyper-Box System, AustriaB-05391518740980On the market Hyper-Box System, CyprusB-05391518741499On the market Hyper-Box System, DenmarkB-05391518740973On the market Hyper-Box System, FinlandB-05391518740690On the market Hyper-Box System, FranceB-05391518740966On the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

Critical warnings

3 warnings recorded — scroll inside the panel to see all entries.

CW007
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.
CW014
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Belgium; available across 1 country total.

Country	On market since	Until
BelgiumPrimary placement		Still on market

Device identification

Trade name: Hyper-Box System, Belgium
UDI-DI code: 05391518740997
Basic UDI-DI: B-05391518740997
Reference / catalog number: G00001-2-BEL
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Hyper-Box System configured for the Belgian market.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

A99DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - OTHER

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification