Organization name

MedFact Engineering GmbH

SRN

DE-MF-000010098

Manufacturer status

Active

7 warnings recorded — scroll inside the panel to see all entries.

• Do not use past indicated date
• Caution, sharp edges

  Before use, Check the device for mechanical surface integrity i.e rough surface, sharp edges, etc.

• Caution

  Before use, the compatibility to other used systems/devices as mentioned in the Instructions for use has to be tested and ensured by the user.

• Do not resterilize
• Do not re-use
• Do not use if package is damaged
• Consult instructions for use

Primary placement in Germany; available across 17 countries total.

Trade name

MagnoConnect I

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.

04255650100464

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.

42556501001-02GK

Reference / catalog number

104-007

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

Connection cable from MedFact mapping and ablation catheters to RF ablation generators.

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.

• C0280ARRYTHMOLOGY DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES

• Class I medical devices in EUDAMED

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