Organization name

MIKIRAD Spółka z ograniczona odpowiedzialnością

SRN

PL-MF-000043814

Manufacturer status

Active

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

• Consult instructions for use

  W czasie korzystania z wyrobu użytkownik powinien przyjąć wyprostowaną pozycję ciała, a wyrób pracować pionowo, tj. w płaszczyźnie równoległej do osi ciała.

Primary placement in Poland; available across 32 countries total.

Trade name

All-purpose walking stick, four-point tip

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.

05908220500100

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.

590639598TF-1_10-14PA

Reference / catalog number

12/MR+13/MR/4

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

The walking stick has a universal handle that can be held with either the left or right hand, and is fitted with a four-point base providing a wide support surface, which increases the user’s stability and and weight-bearing capability. Unlike a standard walking stick with a traditional tip, the four-point base allows the stick to remain upright when the user lets go of the handle, making it easier and safer to use. An additional advantage is the smaller spacing between the four support points compared to a traditional four-point walking stick, which ensures greater comfort and ease when going up and down stairs.

Additional information URL

https://mikirad.com.pl/produkt/laska-inwalidzka-z-uniwersalnym-uchwytem-i-nasadka-czteropunktowa/

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.

• Y120399WALKING DEVICES, ONE-HANDED OPERATION - OTHER

• Class I medical devices in EUDAMED

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