Organization name

Dufner Instrumente GmbH

SRN

DE-MF-000006417

Manufacturer status

Active

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

Primary placement in Germany; available across 32 countries total.

Trade name

ST.MARKS Rectal instruments, 33 cm, 45 / 60 x 130 mm

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.

04063763022708

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.

4063763093009K

Reference / catalog number

24702-33

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

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

https://dufner-tuttlingen.de/en/aufbereitung.php

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.

• L03140102VAGINAL SPREADERS, REUSABLE

• Class I medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.