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

Infusion set IS-103 — Class I MDR by GAMA GROUP a.s.

MD Atlas
GAMA GROUP a.s.

EUDAMED last updated this device on Jan 30, 2024

Infusion set IS-103

85935406TF02ISGRAVITACHE

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: GAMA GROUP a.s.
UDI-DI code: 08593540507785
Reference / catalog number: V606103-ND

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

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 Slovakia; available across 2 countries total.

Country	On market since	Until
SlovakiaPrimary placement		Still on market
Czechia		Still on market

Device identification

Trade name: Infusion set IS-103
UDI-DI code: 08593540507785
Basic UDI-DI: 85935406TF02ISGRAVITACHE
Reference / catalog number: V606103-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)

A03040199INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER

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