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Organization name
UDI-DI code
Reference / catalog number

V204808-54 — IVDR Class A IVDR by GAMA GROUP a.s.

MD Atlas
GAMA GROUP a.s.

EUDAMED last updated this device on Mar 14, 2025

V204808-54

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: 08593540353252
Reference / catalog number: V204808-54

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Manufacturer information

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

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Market distribution

Primary placement in Czechia; available across 2 countries total.

Country	On market since	Until
CzechiaPrimary placement	Jul 1, 2010	Still on market
Slovakia		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08593540353252
Basic UDI-DI: 85935402ODMERKYNAMOCEX
Reference / catalog number: V204808-54
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: No additional information URL provided by the manufacturer.
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