Organization name

KOVAL PROIZVODNJA IN TRGOVINA, D.O.O.

SRN

SI-MF-000003206

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.
• CW136

  EUDAMED did not publish a description for this code.

Primary placement in Slovenia; available across 32 countries total.

Trade name

Shower trolley L1-T1-EL-MAXI 80

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.

03830075920487

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.

383007592KV22A2

Reference / catalog number

10068923

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

Height-adjustable shower trolley with adjustable tilt function, designed for showering and transporting recumbent patients to the showering area. *electric, castors 150 mm, EU cable

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.

• Y093312SHOWER STRETCHERS

• Class I medical devices in EUDAMED

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