Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

P 213.02.Z — IVDR Class A IVDR by SKALAB s.r.o.

MD Atlas
SKALAB s.r.o.

EUDAMED last updated this device on Feb 2, 2026

P 213.02.Z

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: 08594214080221
Reference / catalog number: P 213.02.Z

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

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 08-118432 G8859421408SKAIVDP4On the market 08-118432859421408SKAIVDP4On the market P 012.02.M859421408SKAIVDP4On 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: 08594214080221
Basic UDI-DI: 859421408SKAIVDP4
Reference / catalog number: P 213.02.Z
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: Prostředek se používá jako hemolyzační promývací roztok pro automatické analyzátory glykovaného hemoglobinu firmy ARKRAY ADAMS A1c HA-8180, které pracují na principu vysokoúčinné kapalinové chromatografie (HPLC). Tento produkt je určen k naředění vzorků plné krve a na mytí hadiček, kterými proudí vzorek. Tento produkt je určen pouze pro in vitro použití v laboratořích.
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

Batch number
Expiration date
Manufacturing date
Serial number
Software identification