Pricing Sign in

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Partners 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.

SKALA OK3 Lavážní set — 3 UDI-DI variants, MDR (GAMA GROUP a.s.)

MD Atlas
GAMA GROUP a.s.

Data from EUDAMED, last updated May 23, 2026

SKALA OK3 Lavážní set

85935406TF29SETPROLAVAZEX

3 UDI-DI variants

MDR [Regulation (EU) 2017/745 on medical devices]Class IIa

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Manufacturer: GAMA GROUP a.s.

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?

Device characteristics

Administers medicine

Legacy certificates

Certificate number: 26 0129 QR/NB
Type: refdata.certificate-mdr-type.quality-management-system
Notified body: INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390 (1023)
Validity: Apr 30, 2026 → Apr 29, 2031

Identity & classification

Basic UDI-DI: 85935406TF29SETPROLAVAZEX
Device name: SKALA OK3 Lavážní set
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Version date: Jul 29, 2025

Manufacturer & authorised representative

Manufacturer

Name: GAMA GROUP a.s.
SRN: CZ-MF-000011894
Country: Czechia
Email: gama.jim@gama.cz

Variants by status

UDI-DI variants

3 UDI-DI variants

Sign in to export

Exports are reserved for signed-in users. Sign in or create an account to continue.

Email

Password

No account yet?

Export results

Applied filters

basicUdiUlid01K1AHEVENQFBWA6WTAP7D73B9

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

SKALA OK3-V1 Perfusion set M08593540514073
SKALA OK3-V2 Perfusion set M08593540514080
SKALA OK3-V3 Perfusion set M08593540514097