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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

ARES — IVDR Class A IVDR by Linear Chemicals S.L.U

MD Atlas
Linear Chemicals S.L.U

EUDAMED last updated this device on May 25, 2022

ARES

843528739010H6

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Linear Chemicals S.L.U
UDI-DI code: 8435287390100
Reference / catalog number: 3801000

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Manufacturer information

Organization name: Linear Chemicals S.L.U
SRN: ES-MF-000003284
Manufacturer status: Active

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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.

CW008
Biohazardous Materials.As with all vitro diagnostic equipment, patient samples that are assayed on this system, as well as all waste from the waste container, should be treated as the potentially biohasardous. All materials and mechanical components associated with the sampling and waste system should be handled according to your facility’s biohazard procedure. Use the personal protective equipment recommended by your facility when handling any of these components.
CW259
To use analyser safely, pay attention to the following items: To prevent the risk of electrical shock and/or damage to the instrument Operator should not open the cover of the instrument. Only authorized personnel, for example, service technicians, may open the instrument to perform maintenance or repair. Touching the main board when the power is on may cause severe injury or death. Any problem, please ask for helps from your supplier.
CW258
This symbol means that the labeled item is hot while the instrument is in use. Don’t touch the labeled item as you could burnt. The symbol is labeled on the Front _end’s heater.

Market distribution

Primary placement in Spain; available across 1 country total.

Placed on the market in Spain; per-country availability dates not published.

Device identification

Trade name: ARES
UDI-DI code: 8435287390100
Basic UDI-DI: 843528739010H6
Reference / catalog number: 3801000
Issuing entity: HIBCC

Classification

Risk category: IVDR Class A
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: ARES Coagulation Analyzer
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0202020101SEMI-AUTOMATED COAGULOMETERS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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Expiration date
Manufacturing date
Serial number
Software identification