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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

ALTHEA — 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

ALTHEA

843528739000H3

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: 8435287390001
Reference / catalog number: 3801050

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Manufacturer information

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

Critical warnings

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

CW257
Warning hands pinching: indicates that a certain part of the Neos instrument may produce extrusion, such as automatic door. Reminding user to proceed with appropriate caution.
CW258
High Temp.: indicates that a certain area of the Neos instrument may produce high temperature. Reminding user to pay attention and be careful about burns.
CW008
Biohazard: indicates that a certain area of the Neos instrument can be easily contaminated with biological reagents or samples. Reminding user to timely disinfect this area, keep necessary precautions during operation and take corresponding protective measures at the same time.

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: ALTHEA
UDI-DI code: 8435287390001
Basic UDI-DI: 843528739000H3
Reference / catalog number: 3801050
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: Automatic 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)

W0202020102AUTOMATED COAGULOMETERS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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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.