MDCN TECH D.O.O.

FDA Device Registration & Listing · Ljubljana, SI · Registration 3042940354

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3042940354
FEI Number
3042940354
Entity Name
MDCN TECH D.O.O.
City/State/Country
Ljubljana, SI
Establishment Address
Letaliska cesta 33, Ljubljana 1000, SI
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
MDCN TECH d.o.o. (Owner Number: 10094661)
Owner / Operator Contact Address
Letaliska cesta 33, Ljubljana, SI-061 1000, SI
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

NeoSurround Flex by OmniPEMF NeoSurround by OmniPEMF NeoSurround Flex Arm Pad by OmniPEMF NeoSurround Flex Spine Pad by OmniPEMF NeoSurround Flex Back Pad by OmniPEMF NeoSurround Flex Leg Pad by OmniPEMF NeoSurround Full-Body Mat by OmniPEMF

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ISA Massager, Therapeutic, Electric Physical Medicine Class 1 890.5660 2025-12-15

Official Correspondent

Marko Kadunc

US Agent Details

Stephan Toupin Business: Dawa Medical LLC Email: stoupin@dawamedical.com Phone: (305) 5999373

Related Public Records

Same Entity

MDCN TECH d.o.o.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042940354. Last updated year: 2026. Please use registration number 3042940354 when referencing this establishment in official correspondence.
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