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

V400941 — IVDD — General IVDD by GAMA GROUP a.s.

MD Atlas
GAMA GROUP a.s.

EUDAMED last updated this device on Jan 20, 2026

V400941

B-08593540400796

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: GAMA GROUP a.s.
UDI-DI code: 08593540400796
Reference / catalog number: V400941

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 1, 1995	Still on market
Latvia		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08593540400796
Basic UDI-DI: B-08593540400796
Reference / catalog number: V400941
Issuing entity: GS1

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: sterilizováno radiačním zářením
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W050301020102SAMPLES ANALYSES, PLASTIC TUBES WITHOUT ADDITIVES

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