Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

V204809-55 — IVDR Class A IVDR by GAMA GROUP a.s.

MD Atlas
GAMA GROUP a.s.

EUDAMED last updated this device on Mar 14, 2025

V204809-55

85935402ODMERKYNAMOCEX

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: GAMA GROUP a.s.
UDI-DI code: 08593540353351
Reference / catalog number: V204809-55

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

Organization name: GAMA GROUP a.s.
SRN: CZ-MF-000011894
Manufacturer status: Active

Related devices

150 cm extension PVC tubeB-08593540512093On the market 150 cm extension PVC tube for light-sensitive drugs M85935406TF01PRODHADSVETPDOn the market 150 cm extension PVC tube M85935406TF01PRODLUZHADREOn the market 200 cm extension PVC tube for light-sensitive drugs M85935406TF01PRODHADSVETPDOn the market 50 cm extension PVC tube for light-sensitive drugs M85935406TF01PRODHADSVETPDOn the market

Market distribution

Primary placement in Czechia; available across 2 countries total.

Country	On market since	Until
CzechiaPrimary placement	Jun 29, 2010	Still on market
Slovakia	May 26, 2022	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08593540353351
Basic UDI-DI: 85935402ODMERKYNAMOCEX
Reference / catalog number: V204809-55
Issuing entity: GS1

Classification

Risk category: IVDR Class A
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: https://www.gama.cz/media/files/navody/konicka-odmerka-na-moc-250-ml.jpg
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W05010203URINE COLLECTION, CONTAINERS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Certificates

Certificate health across this manufacturer's portfolio.

26 0129 QR/NBIssued
Quality management systemNotified body: 1023Expiry: Apr 29, 2031
23 0517 QR/NBIssued
Quality management systemNotified body: 1023Expiry: Nov 9, 2028