K-231001-000-X

Organization name

SITIN LAB s.r.o.

SRN

CZ-MF-000023036

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Czechia; available across 1 country total.

Trade name

not provided

UDI-DI code

08594211900003

Basic UDI-DI

859421190001GR

Reference / catalog number

K-231001-000-X

Issuing entity

GS1

Risk category

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

Intended purpose: Anti-decubitus wheelchair seat cushion – a medical device primarily intended to prevent the consequences of long-term sitting with the risk of developing pressure ulcers in the medium risk group. The anti-decubitus seat is an ideal set for preventing the formation of pressure ulcers and pressure sores as a result of prolonged sitting. The product is tailored for the user according to the targeting protocol.

Additional information URL

https://www.geminisystem.cz/

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.

• V08030102NON-ACTIVE ANTI-DECUBITUS MEDICAL CUSHIONS