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

  Nie użytkować przy braku jednej kończyny dolnej

Primary placement in Poland; available across 32 countries total.

Trade name

Single adjustable elbow crutch, fixed support and forearm strap

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.

05908220500049

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-2_01-09PW

Reference / catalog number

04/MR.O

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

Elbow crutch with single-point height adjustment, fixed support and removable forearm strap: • single-point height adjustment (adjustment holes spaced 20 mm apart), • wide, fixed forearm support/clamp with a 10 cm front opening, • universal handle with a non-slip (soft) graphite-coloured insert • two reflectors • cap/foot reinforced with a steel washer, • lightweight, anodised aluminium, • plastic, adjustable forearm strap (removable) • standard colours for plastic components are: black or grey; band in graphite colour. Elbow crutches are technical aids designed to improve the user’s mobility, intended for people with lower limb disabilities (not recommended for those missing a single limb). These are devices with a single point of support featuring a plastic cap, a handle and a fixed or adjustable forearm support, used as a single crutch or a pair of crutches, operated with one hand, for people weighing up to 130 kg. They are made of aluminium components combined with plastic. All MIKIRAD crutches are fitted with a reflector, a rubber cap reinforced with a steel insert, and a secure adjustment system with a double pin fastening. The design features have been developed with user comfort in mind: a practical plastic strap allows the crutch to be comfortably slung over the forearm, leaving the user’s hands free whilst keeping the crutch close at hand.

Additional information URL

https://mikirad.com.pl/wp-content/uploads/2026/03/MIKIRAD-SP.-Z-O.O._Instrukcja-uzytkowania-kul-lokciowych-od-03.2026.pdf

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.

• Y12030601ELBOW CRUTCHES

• Class I medical devices in EUDAMED

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