Organization name

Grzegorz Pałkowski Elektro Med

SRN

PL-MF-000023609

Manufacturer status

Active

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

• CW043

  EUDAMED did not publish a description for this code.
• CW044

  EUDAMED did not publish a description for this code.
• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Poland; available across 29 countries total.

Trade name

Pathosolutions - PCP Plus

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

05905186403339

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

590518640EM-R1802100B3

Reference / catalog number

EM-R18021004

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

IVDR risk classes

IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.

IVDR Class A

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

Zestaw odczynników do usieciowania utrwalonych komórek ludzkich, umożliwiający przygotowanie bloczka parafinowego z materiału cytologicznego.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W01030799HISTOLOGY / CYTOLOGY REAGENTS - OTHER

• IVDR Class A medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.