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Medispec, Ltd.

Also registered as Medi-Spec

Country not established

Medispec, Ltd. is a medical device manufacturer, with 27 devices listed in FDA GUDID, FDA 510(k) and FDA PMA (FDA Class II, I and III) as of 12 Nov 2026.

Devices
27

Registry facts

Counted by deviCERTS from registry records, 12 Nov 2026

Registries
  • FDA GUDID 13
  • FDA 510(k) 12
  • FDA PMA 2

A device listed in two registries counts in both.

Device classes
  • FDA Class II 17
  • FDA Class I 8
  • FDA Class III 2
Sites and related companies
Identifiers
  • DUNS 600300909

What Medispec, Ltd. makes

Medispec, Ltd. manufactures electromechanical and electrohydraulic lithotripsy systems for both extracorporeal and intracorporeal use. Their product portfolio also includes spark-gap orthopaedic extracorporeal shock wave therapy systems, pressure-wave skin and body contouring systems, and hand-held electric massagers.

These products are listed within the FDA 510(k), FDA PMA, and FDA UDI regulatory registries.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue27

Newest first, rows 1-27 of 27

Search and filter all 27 devices
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  • Econolith EM1000 SW-8-A999q

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

  • Econolith EM1000 SW-8-A999m

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

  • Econolith EM1000 SW-8A999b

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

  • Econolith E3000 SW-6-A999b

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

  • Omnispec ED1000 OR-5-A999k

    Listed Registry: GUDID Class:I

  • Econolith E2000 SW-7-A999

    Active Regimes: PMA Registry: GUDID Class:II

  • Orthospec OR-3-A999u

    Active Regimes: PMA Registry: GUDID Class:III

  • Radialspec LS-5-A999b

    Listed Registry: GUDID Class:I

  • Econolith EM1000 SW-8-A999d

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

  • Lithospec LS-6-A999b

    Listed Registry: GUDID Class:II

  • Slimspec LX-5-A999b

    Listed Registry: GUDID Class:I

  • Econolith EM1000 SW-8-A999r

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

  • Econolith E3000 SW-6-A999d

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

  • Uterine Aspiration Curettes(Rigid&Flex) Ref K812426

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

  • Whisk-R Ref K812694

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

  • Medspec Operative Opthalmic Kit Ref K800404

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

  • Sterile Dressing Pack Ref K800490

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

  • Econolith EM1000 Ref K063504

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

  • Omnispec ED1000 Ref K210166

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

  • Clamp Covers Ref K790952

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

  • Lithospec(Tm) Intracorporeal Lithotripter Ref K974796

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

  • Econolith E3000, Model 3000 (Sw-6) Ref K040461

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

  • Disposa-Loops Ref K780548

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

  • Sterile Cast Padding Ref K801554

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

  • Laminaria Japonica Cervical Dilator Ref K833068

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

  • Orthospec Extracorporeal Shock Wave Therapy Device Ref P040026

    Active Regimes: PMA Registry: PMA Class:III

  • Econolith Lithotripter Ref P950043

    Active Regimes: PMA Registry: PMA Class:II

Rows 1-27 of 27

Company details

DUNS number
600300909

Sites1

Frequently asked questions

How many devices does Medispec, Ltd. have in the registry?

The registry currently lists 27 devices for Medispec, Ltd.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Medispec, Ltd.'s devices?

Among its 27 most recently registered devices, Medispec, Ltd. has devices listed in FDA 510(k) (12 devices), FDA PMA (2 devices) and FDA GUDID (13 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Medispec, Ltd.'s devices fall under?

Among its 27 most recently registered devices, the classes recorded for Medispec, Ltd.'s devices are Class I, Class II and Class III. Each device page shows its own class and authorisation.

What are the newest devices from Medispec, Ltd. in the registry?

The most recently registered devices listed for Medispec, Ltd. include Econolith EM1000 SW-8-A999q, Econolith EM1000 SW-8-A999m, Econolith EM1000 SW-8A999b and Econolith E3000 SW-6-A999b.

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