Gondola Professional

by Gondola Medical Technologies SA

Ref EK01.V02Model EK01

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number7649991214Gondola-EK018S Basic UDI-DI 07649991214084UDI-DI	Date12 May 2026Registered	StatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name: Gondola Medical Device
Model / Reference: EK01, EK01.V02

Primary DI / UDI-DI: 07649991214084
Basic UDI-DI: 7649991214Gondola-EK018S
Direct Marketing DI: 07649991214084
EMDN Code: Z129099 Various instruments for functional exploration and therapeutic interventions - other

Device Class: Class IIa
EU market of registration: Italy

Manufacturer details

EUDAMED SRN: CH-MF-000015837
Authorised representative: Veranex Germany GmbH DE-AR-000005578

Other devices from Gondola Medical Technologies SA

Gondola Home

Class IIa

Properties

Other properties (13)

Sterile: No
Implantable: No
Reusable: No
Contains Latex: No
Reprocessed: No
CMR Substance: No
Human-derived: No
Human Tissues: No
Animal Tissues: No
Endocrine Disruptor: No
Administering Medicine: No
Measuring Function: No
Incorporates Medicinal Product: No