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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

AQS — Class IIa MDR by Aurora

MD Atlas
Aurora

EUDAMED last updated this device on Nov 16, 2023

AQS

37700261534151536K

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Aurora
UDI-DI code: 03770026153000
Reference / catalog number: AQS

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Manufacturer information

Organization name: Aurora
SRN: FR-MF-000024055
Manufacturer status: Active

Critical warnings

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

CW273
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 03770026153000
Basic UDI-DI: 37700261534151536K
Reference / catalog number: AQS
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Aqsaniit is a cold plasma sterilizer inteded to sterilize a broad range of thermal-sensitive medical devices.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 625–675 MU29

EMDN nomenclature code(s)

S900199DEVICES FOR GAS PLASMA STERILISATION (EXCLUDING CAT. D - Z) - 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

Related devices

This device is not currently linked to any other device.

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.