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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

LM26 — IVDR Class A IVDR by Labmaster Oy

MD Atlas
Labmaster Oy

EUDAMED last updated this device on Sep 1, 2022

LM26

6429810777LM268N

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Labmaster Oy
UDI-DI code: 06429810777003
Reference / catalog number: LM26

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Manufacturer information

Organization name: Labmaster Oy
SRN: FI-MF-000023942
Manufacturer status: Active

Market distribution

Primary placement in Finland; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 06429810777003
Basic UDI-DI: 6429810777LM268N
Reference / catalog number: LM26
Issuing entity: GS1

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: Labmaster LUCIA™ Analyzer is a semi-automated point-of-care device used in in vitro diagnostics by healthcare professionals in professional healthcare facility environment. Labmaster LUCIA™ Analyzer is used together with Labmaster LUCIA™ test for quantitative or qualitative in vitro diagnostic analysis of analytes. LUCIA Analyzer measures CECL (cathodic electrochemiluminescence) signals and calculates analyte concentrations based on emission signals emitted from LUCIA cassettes.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0201069099VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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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.