Organization name

Grzegorz Pałkowski Elektro Med

SRN

PL-MF-000023609

Manufacturer status

Active

Primary placement in Poland; available across 29 countries total.

Trade name

Pathosolutions PREMIUM - Embedding cassette with triangular holes, one-piece with integral lid, in taped stacks, BLUE

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.

05905186402738

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-C1700400ZP

Reference / catalog number

EM-C1700400B

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

—

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.

• W05030580DEVICES FOR PATOLOGY TESTS - ACCESSORIES

• IVDR Class A medical devices in EUDAMED

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