Organization name

Merck KGaA

SRN

DE-MF-000018777

Manufacturer status

Active

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

• CW010

  Consult instructions for use

Primary placement in Germany; available across 1 country total.

Trade name

Eosin Y solution 1%, alcoholic for microscopy

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.

04027269671198

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.

4027269117081VA

Reference / catalog number

1170811000

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

This “Eosin Y solution 1%, alcoholic - for microscopy” is used for human- medical cell diagnosis and serves the histological and clinico- cytological investigation of sample material of human origin. It is a staining solution that when used together with other in vitro diagnostic products from our portfolio makes target structures evaluable for diagnostic purposes (by fixing, embedding, staining, counterstaining, mounting) in histological and clinico- cytological specimen materials, for example histological sections of e. g. the kidney, muscle tissue, heart, or lung. The hematoxylin and eosin (H&E) staining method is the method most frequently used for the staining of histology material. This Eosin Y solution is a 1% alcoholic staining solution, that can be used e. g. for the histological staining of instantaneous sections. Unstained structures are relatively low in contrast and are extremely diffi - cult to distinguish under the light microscope. The images created using the staining solutions help the authorized and qualified investigator to better define the form and structure in such cases. Further examinations ma y be necessary to reach a definitive diagnosis.

Additional information URL

https://www.sigmaaldrich.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.

• W01030708STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY)

• IVDR Class A medical devices in EUDAMED

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