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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

THERMA NE ESR autoanalyzer — IVDR Class A IVDR

MD Atlas
Linear Chemicals S.L.U

EUDAMED last updated this device on May 26, 2022

THERMA NE ESR autoanalyzer

843528739430HY

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: 8435287394306
Reference / catalog number: 5810025

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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.

CW273
This Instrument is an electro mechanic device of which the user may not handle the internal parts. For any technical issue, contact the Technical Service of your Distributor, whose staff is trained and qualified to carry out any repairs.
CW010
EUDAMED did not publish a description for this code.

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: THERMA NE ESR autoanalyzer
UDI-DI code: 8435287394306
Basic UDI-DI: 843528739430HY
Reference / catalog number: 5810025
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: THERMA NE ESR autoanalyzer
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W02029001ERYTHROCYTE SEDIMENTATION RATE DEVICES

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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Software identification