Organization name

REH4MAT Spółka z ograniczoną odpowiedzialnością

SRN

PL-MF-000009271

Manufacturer status

Active

Primary placement in Poland; available across 31 countries total.

Trade name

ORTREZA KOŃCZYNY GÓRNEJ

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.

05900949768779

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.

59009497OKG-27M4

Reference / catalog number

OKG-27 XL

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

Orteza kończyny górnej odciąża i stabilizuje kończynę górną. Stosowana w przypadku zespołów bólowych i urazów w obrębie kończyny górnej.

Additional information URL

https://www.reh4mat.com/produkt/stabilizacja-barku/okg-27/

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.

• Y060621SHOULDER ORTHOSES

• Class I medical devices in EUDAMED

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