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EMS Handels Gesellschaft m.b.H.

Active in EUDAMED

Austriafrom SRN EUDAMED FDA SRN AT-MF-000002599 FEI 3007701713

Devices
7
Registrations
EUDAMEDFDA
FDA recalls
0

At a glance

Counted by deviCERTS from registry records

EU certificates

2 of 2 in force.

See certificates

Market reach

European Union
EUDAMED actor, 2 certificates
United States
FDA FEI

Catalogue7

Newest first, rows 1-7 of 7

  • EMS Neurostimulator Ref EMS/NS

    Class IIa
    Active CE MDD EUDAMED IIa

  • Angelie EIS Ref ANG/EIS

    Class IIa
    Active CE MDD EUDAMED IIa

  • Surpass Ref SP/EMG/EP

    Class IIa
    Active CE MDR EUDAMED IIa

  • Surpass LT Ref SPLT/EMG/EP

    Class IIa
    Active CE MDR EUDAMED IIa

  • Sienna Ultimate Ref SU/EEG

    Class IIa
    Active CE MDR 510(k) EUDAMED510(k) IIa

  • Unique+ Ref UP2200-10

    Class IIa
    Active CE MDD EUDAMED IIa

  • Sienna Ref SE/EEG

    Class IIa
    Active CE MDR EUDAMED IIa

Company details

EUDAMED SRN
AT-MF-000002599
FDA FEI number
3007701713
EU VAT number
ATU18380801
EUDAMED status
Active
EUDAMED registered name
EMS Handels Gesellschaft m.b.H.
EUDAMED abbreviated name
EMS Biomedical
Registered address
1, Jochingergasse, 2100, Korneuburg, Austria
Phone
+43 2262 616550
PRRC contact
Ruzena Ortnerova(public in EUDAMED)

EUDAMED certificates2

2 certificates2 valid, 0 expiredMDR 2next expiry 19 Jun 2029

EUDAMED certificates (2)

3EC International a.s. 2265 2 certificates

  • 2024-MDR/QS-030 Issued

    Quality management system EU MDR

    Issued
    19 Jun 2024
    Expires
    19 Jun 2029
  • 2025-MDR/QS-055 Issued

    Quality management system EU MDR

    Issued
    9 Nov 2025
    Expires
    19 Jun 2029

From the company website

Read 18 Sep 2026

electromyography and evoked potentials (EMG/EP), electroencephalography (EEG), Neuro Monitoring in ICU and NICU, cerebral function monitoring (CFM), Polysomnography (PSG), brain motor control assessment (BMCA), event related potentials (ERP), ambulatory EEG (AEEG), long term monitoring (LTM), continuous EEG (cEEG), intraoperative monitoring (IOM) applications, Electrical Impedance Segmentography (EIS)

From the manufacturer's own website, in their original language. Source

Frequently asked questions

How many devices does EMS Handels Gesellschaft m.b.H. have in the registry?

The registry currently lists 7 devices for EMS Handels Gesellschaft m.b.H.. Devices recorded under merged duplicate company entries are counted once.

Which registries list EMS Handels Gesellschaft m.b.H.'s devices?

Among its 7 most recently registered devices, EMS Handels Gesellschaft m.b.H. has devices listed in EUDAMED (7 devices) and FDA 510(k) (1 device). A device can be listed in more than one registry, so these counts overlap.

What risk classes do EMS Handels Gesellschaft m.b.H.'s devices fall under?

Among its 7 most recently registered devices, the classes recorded for EMS Handels Gesellschaft m.b.H.'s devices are Class IIa. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for EMS Handels Gesellschaft m.b.H.?

EUDAMED lists 2 certificates for EMS Handels Gesellschaft m.b.H. (quality management system) under MDR. 2 are recorded with the status issued. The most recent was issued on 2025-11-09.

What are the newest devices from EMS Handels Gesellschaft m.b.H. in the registry?

The most recently registered devices listed for EMS Handels Gesellschaft m.b.H. include EMS Neurostimulator, Angelie EIS, Surpass and Surpass LT.

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