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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

08-118432 G8 — IVDR Class A IVDR by SKALAB s.r.o.

MD Atlas
SKALAB s.r.o.

EUDAMED last updated this device on Feb 2, 2026

08-118432 G8

859421408SKAIVDP4

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: SKALAB s.r.o.
UDI-DI code: 08594214080047
Reference / catalog number: 08-118432 G8

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Manufacturer information

Organization name: SKALAB s.r.o.
SRN: CZ-MF-000029744
Manufacturer status: Active

Related devices

P 413.01859421408SKAIVDP4On the market 206859421408SKAIVDP4On the market 08-118432859421408SKAIVDP4On the market P 012.02.M859421408SKAIVDP4On the market P 012.02.Z859421408SKAIVDP4On the market

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.

Market distribution

Primary placement in Czechia; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 08594214080047
Basic UDI-DI: 859421408SKAIVDP4
Reference / catalog number: 08-118432 G8
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: HbA1C Hemolysis se používá jako hemolyzační roztok pro automatické analyzátory glykovaného hemoglobinu TOSOH BIOSCIENCE G8, které pracují na principu vysokoúčinné kapalinové chromatografie (HPLC).
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W01019099CLINICAL CHEMISTRY REAGENTS - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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