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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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Gondola Medical Device — 2 UDI-DI variants, MDR

MD Atlas
Gondola Medical Technologies SA

Data from EUDAMED, last updated May 23, 2026

Gondola Medical Device

7649991214Gondola-EK018S

2 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: Gondola Medical Technologies SA

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Device characteristics

Active device

Identity & classification

Basic UDI-DI: 7649991214Gondola-EK018S
Device name: Gondola Medical Device
Device model: EK01
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Version date: May 12, 2026

Manufacturer & authorised representative

Manufacturer

Name: Gondola Medical Technologies SA
SRN: CH-MF-000015837
Country: Switzerland
Email: qara@gondola-medical.com
Phone: +41 91 921 38 38

Authorised representative

Name: Veranex Germany GmbH
SRN: DE-AR-000005578
Country: Germany

Variants by status

UDI-DI variants

2 UDI-DI variants

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Applied filters

basicUdiUlid01KRE77QTB7W0287Y0PWFVZZ4P

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

EK01.V0107649991214015
EK01.V0207649991214084