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Leisegang Feinmechanik-Optik GmbH

Active in EUDAMED

Germanyfrom SRN EUDAMED FDA SRN DE-MF-000006525 FEI 3002807462

Devices
14
Registrations
EUDAMEDFDA
FDA recalls
0

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA FEI

What Leisegang Feinmechanik-Optik GmbH makes

Leisegang Feinmechanik-Optik GmbH manufactures colposcopes, which are optical instruments used for examining the cervix, vagina, and vulva to detect abnormalities such as precancerous cells or infections. These devices are designed for clinical use in gynecological settings, providing magnified visualization of tissue surfaces. The colposcopes are intended for diagnostic procedures and support in cervical cancer screening. They incorporate lighting and magnification systems to enhance visibility of tissue details during examination.

The company’s colposcopes fall under Class I medical devices in the EU regulatory framework and are listed in the EUDAMED database. These devices comply with EU Medical Device Regulations (MDR) or the previous Medical Device Directive (MDD) as applicable. The manufacturer is based in Germany and adheres to EU requirements for device classification and registration.

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

Catalogue14

Newest first, rows 1-14 of 14

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  • Colposcope Ref BG005380

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Colposcope Ref BG006750

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Colposcope Ref BG005400

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Colposcope Ref BG005100

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Colposcope Ref BG002680

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Colposcope Ref BG000290

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Colposcope Ref BG005000

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Colposcope Ref BG006708

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Colposcope Ref BG005388

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Colposcope Ref BG002688

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Colposcope Ref BG005300

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Colposcope Ref BG000280

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Colposcope Ref BG002390

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Colposcope Ref BG006700

    Active Regimes: CE MDR Registry: EUDAMED Class:I

Rows 1-14 of 14

Company details

EUDAMED SRN
DE-MF-000006525
FDA FEI number
3002807462
EUDAMED status
Active
EUDAMED registered name
Leisegang Feinmechanik-Optik GmbH
Registered address
32, Leibnizstr., 10625, Berlin, Germany
PRRC contact
Falko Sandmann(public in EUDAMED)

From the company website

Read 18 Oct 2026

Thus, the clarification colposcopy is now billable. Leisegang colposcopes meet all equipment requirements according to the quality assurance agreement.

Translated from the manufacturer's own website. Source

Frequently asked questions

How many devices does Leisegang Feinmechanik-Optik GmbH have in the registry?

The registry currently lists 14 devices for Leisegang Feinmechanik-Optik GmbH. Devices recorded under merged duplicate company entries are counted once.

Which registries list Leisegang Feinmechanik-Optik GmbH's devices?

Among its 14 most recently registered devices, Leisegang Feinmechanik-Optik GmbH has devices listed in EUDAMED (14 devices).

What risk classes do Leisegang Feinmechanik-Optik GmbH's devices fall under?

Among its 14 most recently registered devices, the classes recorded for Leisegang Feinmechanik-Optik GmbH's devices are Class I. Each device page shows its own class and authorisation.

What are the newest devices from Leisegang Feinmechanik-Optik GmbH in the registry?

The most recently registered devices listed for Leisegang Feinmechanik-Optik GmbH include Colposcope.

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