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Formatk Systems Ltd

Active in EUDAMED

Israelfrom SRN EUDAMED SRN IL-MF-000022933

Formatk Systems Ltd is a medical device manufacturer based in Israel, with 41 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II and I; EU Class IIa) as of 13 Nov 2026.

Devices
41
Registrations
EUDAMED

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • FDA GUDID 36
  • EUDAMED 28
  • FDA 510(k) 4

A device listed in two registries counts in both.

Device classes
  • FDA Class II 35
  • FDA Class I 5
  • EU Class IIa 1
Top EMDN categories
Sites and related companies
Identifiers
  • EUDAMED SRN IL-MF-000022933
  • DUNS 532396673

At a glance

Counted by deviCERTS from registry records

EU certificates

1 of 1 in force.

See certificates

Market reach

European Union
EUDAMED actor, 1 certificate

What Formatk Systems Ltd makes

The company manufactures dermatological and cosmetic treatment devices, including diode lasers, radio-frequency applicators, and light-energy systems for skin surface treatments. Their portfolio also includes multi-modality treatment systems, laser beam guiding handpieces, and electromechanical transport trolleys for medical and aesthetic procedures. Skin abrasion units and professional red-light phototherapy systems are also part of their offerings. These devices are designed for professional use in clinical and cosmetic settings.

The company’s devices are regulated under FDA classifications, with products falling into Class I and Class II categories. They are listed in the FDA’s 510(k) and UDI registries, ensuring compliance with U.S. medical device authorization requirements. The manufacturer operates from the United States.

AI-generated from registry data, 20 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue41

Newest first, rows 1-41 of 41

Search and filter all 41 devices
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  • R-Sonic Ref FS10010*

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Magma Spark Cart FS80001

    Active Regimes: 510(k) Registry: GUDID Class:I

  • B-Hr FS10006

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

  • Magma FS70000

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

  • F-Hr* FS10003

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

  • St FS10011

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

  • Alpha FS90000

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

  • Magma Spark Plus FS90000

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

  • DioBreeze FS80020

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Forma Light FS60000

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

  • Forma FS10000

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

  • F-Hr FS10002

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

  • Magma Spark FS80000

    Active Regimes: 510(k) Registry: GUDID Class:II

  • S-530 FS90012

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

  • HR-Mini FS80021

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

  • F-Ac FS10005

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

  • Ald FS70001

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

  • Plg FS10009

    Active Regimes: 510(k) Registry: GUDID Class:I

  • Hr FS60002

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

  • HR-Max FS80022

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

  • DioBreeze Cart FS80023

    Active Regimes: 510(k) Registry: GUDID Class:I

  • F-Sr FS10004

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

  • Hr* FS60003

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

  • S-590 FS90013

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

  • Lld FS70007

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

  • iProElite FS10000-3

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Forma Cart FS10001

    Active Regimes: 510(k) Registry: GUDID Class:I

  • B-Sr FS10008

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

  • L-530 FS90014

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

  • Sr FS60001

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

  • Sheerwave Plus IPLaser 360

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Magma Spark Pro FS90000

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

  • S-430 FS90011

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

  • iProElite Cart FS10001-3

    Active Regimes: 510(k) Registry: GUDID Class:I

  • L-650 FS90015

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

  • B-Hr* FS10007

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

  • FS70002

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

  • Forma System, Forma Light System Ref K160195

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Magma System Ref K153566

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Magma Spark Pro (Magma Spark Plus, Alpha) Ref K183307

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Magma Spark Ref K162781

    Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 1-41 of 41

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
IL-MF-000022933
DUNS number
532396673
EU VAT number
514102102
EUDAMED status
Active
EUDAMED registered name
Formatk Systems Ltd.
Registered address
3, Hayozma St., 3903203, Tirat Hacarmel,, Israel
Website
forma-tk.com/
Phone
+97248571848
PRRC contact
Lilia Schlosberg(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 13 Apr 2028

EUDAMED certificates (1)

DNV MEDCERT GmbH 0482 1 certificate

  • 7304GB448250318 Active Supplemented

    Quality management system EU MDR

    Issued
    18 Mar 2025
    Expires
    13 Apr 2028
    Reason
    Add device or group

Sites1

Frequently asked questions

How many devices does FORMATK SYSTEMS LTD have in the registry?

The registry currently lists 41 devices for FORMATK SYSTEMS LTD. Devices recorded under merged duplicate company entries are counted once.

Which registries list FORMATK SYSTEMS LTD's devices?

Among its 41 most recently registered devices, FORMATK SYSTEMS LTD has devices listed in EUDAMED (28 devices), FDA 510(k) (4 devices) and FDA GUDID (36 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do FORMATK SYSTEMS LTD's devices fall under?

Among its 41 most recently registered devices, the classes recorded for FORMATK SYSTEMS LTD's devices are Class I, Class IIa and Class II. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for FORMATK SYSTEMS LTD?

EUDAMED lists 1 certificate for FORMATK SYSTEMS LTD (quality management system) under MDR. The most recent was issued on 18 Mar 2025.

What are the newest devices from FORMATK SYSTEMS LTD in the registry?

The most recently registered devices listed for FORMATK SYSTEMS LTD include R-Sonic, Magma Spark Cart FS80001, B-HR FS10006 and Magma FS70000.

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