Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010755771

FEI Number

3010755771

Entity Name

MDT SP. Z O.O.

City/State/Country

KRAKOW Malopolskie, PL

Establishment Address

UL. SKOSNA 12A, KRAKOW Malopolskie 30-383, PL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MDT sp. z o.o. (Owner Number: 10048232)

Owner / Operator Contact Address

UL. SKOSNA 12A, KRAKOW, PL-12 30-383, PL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SC-1 OC-1 PRO 1000 EVO TRU-1000 TRU-2500 PRO 500 PRO 1000 PRO 80 TRU-2000 TRU-800 EASY SMART PLUS EASY PLUS ECO PLUS TOROS UNIQ PA-1000 T-LT T-S T-L T-P PA-3000

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HME	Chair, Ophthalmic, Ac-Powered	Ophthalmic	Class 1	886.1140	2014-12-19
HMF	Stand, Instrument, Ac-Powered, Ophthalmic	Ophthalmic	Class 1	886.1860	2014-12-19
HMG	Stand, Instrument, Ophthalmic, Non-Powered	Ophthalmic	Class 1	886.1860	2014-12-19

Official Correspondent

Anna Marcinik

US Agent Details

David L. Rosen Business: Foley & Lardner LLP Email: DRosen@foley.com Phone: (202) 6725430

Related Public Records

Same Entity

MDT sp. z 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 3010755771. Last updated year: 2026. Please use registration number 3010755771 when referencing this establishment in official correspondence.