Organization name

BY CONNIEHANSEN 2015 ApS

SRN

DK-MF-000043166

Manufacturer status

Active

Primary placement in Denmark; available across 32 countries total.

Trade name

PETRA

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.

57440047000010

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.

5744004700001W2

Reference / catalog number

01

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

PETRA frame runner is our all-round steel frame in 7 sizes from (-2) to 5. for users from 10 months to adult. with reduced strength and mobility function.Size. 1-5 have a drop-down saddle section

Additional information URL

https://by-conniehansen.com/manuals/

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.

• Y122799NON-MOTORIZED VEHICLES AND MEANS OF TRANSPORT - OTHER

• Class I medical devices in EUDAMED

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