Organization name

Avantor Performance Materials Poland S.A.

SRN

PL-MF-000037589

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Poland; available across 28 countries total.

Trade name

Formaldehyde 4% - Cubitainer (Bag-in-box)

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.

07312056761228

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.

590774W032JA

Reference / catalog number

KP4078.9010

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

The product is used for the histological examination of samples derived from the human body.

Additional information URL

https://eifu.vwr.com/

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.

• W01030705FIXING REAGENTS (HISTOLOGY/CYTOLOGY)

• IVDR Class A medical devices in EUDAMED

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