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Sapi Med SpA

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Sapi Med SpA is a medical device manufacturer, with 13 devices listed in FDA GUDID and EUDAMED (FDA Class II) as of 14 Nov 2026.

Devices
13

Registry facts

Counted by deviCERTS from registry records, 14 Nov 2026

Registries
  • FDA GUDID 13
  • EUDAMED 11

A device listed in two registries counts in both.

Device classes
  • FDA Class II 13
Identifiers
  • DUNS 437320088

What Sapi Med SpA makes

SAPI Med produces single-use optical devices for rectal and anal examinations, including anoscope and proctoscope models, as well as battery-powered endoscopic light sources and accessories like light adaptors. Their portfolio also includes haemorrhoid treatment tools such as ligators and retractors, designed for procedural use in clinical settings.

The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. SAPI Med operates from the United States.

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

Catalogue13

Newest first, rows 1-13 of 13

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  • Listed Registry: GUDID Class:II
  • LEM Suction LEM with bands

    Active Regimes: CE MDD 510(k) Registry: EUDAMEDGUDID Class:II
  • Rectoscope A.4519

    Active Regimes: CE MDD 510(k) Registry: EUDAMEDGUDID Class:II
  • Anoscope A.4019

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Epoflier Surgical retractor

    Active Regimes: CE MDR CE MDD 510(k) Registry: EUDAMEDGUDID Class:II
  • Haemorrhoid ligator A.5660

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II
  • Retractor A.4081

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II
  • Self-light anoscopes Operative Self-Led-Light

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II
  • Rectoscope A.4522

    Active Regimes: CE MDR CE MDD 510(k) Registry: EUDAMEDGUDID Class:II
  • Self-Suction-LEM with 3 bands

    Active Regimes: CE MDR CE MDD 510(k) Registry: EUDAMEDGUDID Class:II
  • Anoscope A.4023.1

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II
  • LEM Traction LEM with rind loader

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II
  • Pen LED light

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:II

Rows 1-13 of 13

Company details

DUNS number
437320088

Frequently asked questions

How many devices does SAPI MED SPA have in the registry?

The registry currently lists 13 devices for SAPI MED SPA. Devices recorded under merged duplicate company entries are counted once.

Which registries list SAPI MED SPA's devices?

Among its 13 most recently registered devices, SAPI MED SPA has devices listed in EUDAMED (11 devices) and FDA GUDID (13 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do SAPI MED SPA's devices fall under?

Among its 13 most recently registered devices, the classes recorded for SAPI MED SPA's devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from SAPI MED SPA in the registry?

The most recently registered devices listed for SAPI MED SPA include Adaptor Fiber cable adaptor, LEM Suction LEM with bands, Rectoscope A.4519 and Anoscope A.4019.

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