Organization name

Merck KGaA

SRN

DE-MF-000018777

Manufacturer status

Active

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• CW010

  Consult instructions for use

Primary placement in Germany; available across 1 country total.

Trade name

Entellan™ new rapid mounting medium 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.

04022536098340

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.

4027269107961W6

Reference / catalog number

1079610500

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

These ready-to-use anhydrous mounting media are suited for mounting dehydrated sample material of human origin after these have been fixed and embedded as necessary, and then histologically, bacteriologically, he - matologically (enzyme-cytochemically), or cytologically stained and, where applicable, counterstained with other in vitro diagnostic products from our portfolio, thus making them evaluable for further diagnostic procedures. Samples are mounted on slides to enable the specimen material to be examined by light microscopy, at the same time preserving it and thus enabling it to be re-examined many years later. The appropriate anhydrous mounting medium for the respective application is given in the corresponding instructions for use for our In Vitro Diagnostic staining solutions, solid dyes, and test kits. Using the auxiliary reagents from our portfolio creates the conditions that enable authorized and qualified investigators to make a correct diagnosis at the end of the diagnostic process. In this regard, auxiliary IVD reagents serve inter alia to process human specimen material (e. g. fixing, decalcify - ing, dehydrating, clarifying, paraffin-embedding, mounting, microscoping, archiving). When used together with the corresponding staining solutions, this enables the visualization of cellular structures that are otherwise low in contrast, thus rendering them evaluable under the optical microscope. Further examinations may 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.

• W01030706MOUNTING MEDIA (HISTOLOGY/CYTOLOGY)

• IVDR Class A medical devices in EUDAMED

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