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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

CERES — 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

CERES

843528739020H9

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: 8435287390209
Reference / catalog number: 3801100

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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

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

CW008
Alert user to operate under description; otherwise maybe result in infection danger by biology.
CW011
Alert users to operate under description, otherwise maybe result in damage to system or affect test result.

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: CERES
UDI-DI code: 8435287390209
Basic UDI-DI: 843528739020H9
Reference / catalog number: 3801100
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: CERES 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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Software identification