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MEDIST, s.r.o.

Slovakia SK-MF-000004422 Last updated 17 Sep 2026

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Devices
16
Registries
EUDAMED
FDA recalls
0

Catalogue16

EUDAMED certificates1

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

EUDAMED certificates (1)

3EC International a.s. 2265 1 certificate

  • 2022-MDR/QS-022 Issued

    Quality management system EU MDR

    Issued
    27 Sep 2022
    Expires
    27 Sep 2027

Notified bodies

About

Slovenský výrobkov súčačeňov MEVACS has been developing, manufacturing and service for hospitals and clinics since 1997. Over 14,000 devices, exports to 50 countries.

Translated from the manufacturer's own website. Source

What MEDIST, s.r.o. makes

MEDIST, s.r.o. manufactures a range of medical suction devices, including portable and modular models such as the MEVACS M20, M30, M40, and M90 series, each designed with accompanying accessories for clinical use. These devices are intended for healthcare settings to remove fluids, secretions, or obstructions from patients during medical procedures or ongoing care.

The company’s suction devices fall under EU Class IIa medical devices and are registered in the EUDAMED database. MEDIST, s.r.o. is based in Slovakia and adheres to EU regulatory requirements for these products.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does MEDIST, s.r.o. manufacture?

MEDIST, s.r.o. specializes in manufacturing medical suction devices, specifically the MEVACS series. These include portable and modular models like the MEVACS M20, M30, M40, M90, and M38, along with their respective accessories. These devices are designed for clinical use to aspirate fluids, secretions, or obstructions from patients during medical procedures or ongoing care.

Where is MEDIST, s.r.o. based?

MEDIST, s.r.o. is based in Slovakia, where it develops, manufactures, and services its medical suction devices for healthcare settings.

Are MEDIST, s.r.o.’s devices listed in any regulatory registries?

Yes, MEDIST, s.r.o.’s medical suction devices are registered in the EUDAMED database, which is the European Union’s central registry for medical devices. This registration ensures transparency and compliance with EU regulatory requirements.

How are MEDIST, s.r.o.’s medical suction devices classified under EU regulations?

MEDIST, s.r.o.’s medical suction devices fall under EU Class IIa, which is the second-lowest risk classification for medical devices. This classification applies due to their intended use in aspirating bodily fluids and secretions, where performance and safety are critical but not as high-risk as invasive procedures.

Why are MEDIST, s.r.o.’s devices listed as Class IIa rather than a higher or lower class?

The Class IIa designation for MEDIST’s suction devices reflects their moderate risk level. While they are essential for clinical use—removing fluids or obstructions—they do not involve invasive procedures or life-support functions, which would elevate them to a higher class. Conversely, they are not simple enough (like a thermometer) to qualify for Class I, hence the Class IIa classification under EU regulations.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
Slovakia
Address
455/4, PETRUSOVSKEHO, Humenné, Slovakia
Website
www.medist.sk
Phone
+421905323690
PRRC contact
Pavol Šompľak
EUDAMED SRN
SK-MF-000004422