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FOTONA, proizvodnja optoelektronskih naprav d.o.o.

Active in EUDAMED

Sloveniafrom SRN EUDAMED SRN SI-MF-000000126

Devices
30
Registrations
EUDAMED

At a glance

Counted by deviCERTS from registry records

EU certificates

2 of 2 in force.

See certificates

Market reach

European Union
EUDAMED actor, 2 certificates

Catalogue30

Newest first, rows 1-30 of 30

Search and filter all 30 devices
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  • SkyWave Ref M321-B

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • StarFormer IntimaWave Chair Ref 105780

    Expiring Regimes: CE MDR Registry: EUDAMED Class:IIa

  • StarFormer Applicator Ref Radial XLarge

    Expiring Regimes: CE MDR Registry: EUDAMED Class:IIa

  • StarFormer Applicator Ref Radial Large

    Expiring Regimes: CE MDR Registry: EUDAMED Class:IIa

  • TimeWalker AT Ref M021-5AF/1

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • StarFormer Ref M008-3T

    Expiring Regimes: CE MDR Registry: EUDAMED Class:IIa

  • SkyPulse Ref M321-B

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • SkyPulse Ref M321-A

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • LightWalker AT S Ref M021-5AF/1 S

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • AvalancheLase Ref M071-2F/LXP

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • TimeWalker ST-E Ref M002-6A/2

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • StarWalker Ref M031-3A/2 PQX

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • TimeWalker AT Ref M021-5AF/1

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • StarWalker Ref M031-3A/2 QX

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • SkyPulse Ref M321-B

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • StarWalker Ref M031-3A/2 MAQX

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • LightWalker AT Ref M021-5AF/1

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • XPulse Ref 1064 nm

    Withdrawn Regimes: CE MDR, withdrawn Registry: EUDAMEDGUDID Class:IIb

  • XS Dynamis Ref M002-2A

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • SP Spectro Ref M021-4AF/3

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • StarFormer Ref M008-3T

    Expiring Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:IIa

  • SkyPulse Ref M321-A

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:IIb

  • LightWalker ST-E ADVANCED Ref M002-6A/2 ADVANCED

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • LightWalker ST-E PRO Ref M002-6A/2 PRO

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • LightWalker AT S Ref M021-5AF/1 S

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • AvalancheLase Ref M071-2F/LX

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • SP Dynamis Ref M021-4AF/3

    Active Regimes: CE MDR CE MDD Registry: EUDAMEDGUDID Class:IIb

  • XP Dynamis Ref M001-12F

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • StarWalker Ref M031-3A/2 PICO Pro

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:IIb

  • LightWalker ST-E ADVANCED Ref M002-6A/2 ADVANCED

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

Rows 1-30 of 30

Company details

EUDAMED SRN
SI-MF-000000126
EU VAT number
16890914
EUDAMED status
Active
EUDAMED registered name
FOTONA, proizvodnja optoelektronskih naprav d.o.o.
EUDAMED abbreviated name
Fotona d.o.o.
Registered address
7, Stegne, 1000, Ljubljana, Slovenia
PRRC contact
Marko Berdajs(public in EUDAMED)

EUDAMED certificates2

2 certificates2 valid, 0 expiredMDR 2next expiry 18 Jan 2027

EUDAMED certificates (2)

3EC International a.s. 2265 1 certificate

  • 2022-MDR/QS-021/A Expiring Expires in 323 days

    Quality management system EU MDR

    Issued
    26 Sep 2023
    Expires
    21 Sep 2027

TÜV SÜD Product Service GmbH 0123 1 certificate

  • G10 025155 0029 Expiring Expires in 77 days

    Quality management system EU MDR

    Issued
    12 Feb 2024
    Expires
    18 Jan 2027

Frequently asked questions

How many devices does FOTONA, proizvodnja optoelektronskih naprav d.o.o. have in the registry?

The registry currently lists 30 devices for FOTONA, proizvodnja optoelektronskih naprav d.o.o.. Devices recorded under merged duplicate company entries are counted once.

Which registries list FOTONA, proizvodnja optoelektronskih naprav d.o.o.'s devices?

Among its 30 most recently registered devices, FOTONA, proizvodnja optoelektronskih naprav d.o.o. has devices listed in EUDAMED (30 devices) and FDA GUDID (25 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do FOTONA, proizvodnja optoelektronskih naprav d.o.o.'s devices fall under?

Among its 30 most recently registered devices, the classes recorded for FOTONA, proizvodnja optoelektronskih naprav d.o.o.'s devices are Class IIa and Class IIb. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for FOTONA, proizvodnja optoelektronskih naprav d.o.o.?

EUDAMED lists 2 certificates for FOTONA, proizvodnja optoelektronskih naprav d.o.o. (quality management system) under MDR. 2 are recorded with the status issued. The most recent was issued on 12 Feb 2024.

What are the newest devices from FOTONA, proizvodnja optoelektronskih naprav d.o.o. in the registry?

The most recently registered devices listed for FOTONA, proizvodnja optoelektronskih naprav d.o.o. include SkyWave, StarFormer IntimaWave Chair, StarFormer Applicator and TimeWalker AT.

Generated automatically from registry data and not verified by a human reviewer.