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

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Organization name
UDI-DI code
Reference / catalog number

Flow regulator infusion — Class I MDR by GAMA GROUP a.s.

MD Atlas
GAMA GROUP a.s.

EUDAMED last updated this device on Jan 26, 2024

Flow regulator infusion

85935406TF02REGULATORPRS3

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: GAMA GROUP a.s.
UDI-DI code: 08593540512154
Reference / catalog number: V606145-ND

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Manufacturer information

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

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Critical warnings

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

CW011
Čtěte návod k použití
CW001
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.
CW083
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Czechia; available across 1 country total.

Placed on the market in Czechia; per-country availability dates not published.

Device identification

Trade name: Flow regulator infusion
UDI-DI code: 08593540512154
Basic UDI-DI: 85935406TF02REGULATORPRS3
Reference / catalog number: V606145-ND
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on 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)

A03010103INFUSION CONTROLLERS WITH FLOW REGULATOR

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

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