Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010067993

FEI Number

3010067993

Entity Name

MEDEN-INMED, SP. Z O.O.

City/State/Country

Koszalin Zachodniopomorskie, PL

Establishment Address

ul. Wenedow 2, Koszalin Zachodniopomorskie 75-847, PL

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Meden-Inmed (Owner Number: 10042090)

Owner / Operator Contact Address

ul. Wenedow 2, Koszalin, PL-32 75-847, PL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Triton table Galaxy table Montane Table PhysioGait ELEVEO

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
INQ	Table, Powered	Physical Medicine	Class 1	890.3760	2012-10-18
FSA	Lift, Patient, Non-Ac-Powered	General Hospital	Class 1	880.5510	2016-06-24

Official Correspondent

Marta Tyszka

US Agent Details

Dave Hunter Email: dave.hunter@djoglobal.com Phone: (858) 2458747

Related Public Records

Same Entity

Meden-Inmed

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2018	Handicare Usa Inc	1	PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered
Z-0014-2018	Handicare AB Maskinvagen	1	Carina Mobile Lifts, Models: a) Carina350EM, REF 6060011 b) Carina350EML, REF 60600012 c) Carina350EE, REF 60600009

Similar Registrations

Registration Number	Establishment Name	Location
3008899703	HAVEN MEDICAL, LLC	Grand Haven, MI, US
3008887767	TYROMOTION GMBH	Graz Steiermark, AT
3016678044	ETAC POLAND SP. Z O.O.	Tczew Pomorskie, PL
2510425	Hill Laboratories	Frazer, PA, US
3008261413	DJO CANADA INC.	Mississauga Ontario, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010067993. Last updated year: 2026. Please use registration number 3010067993 when referencing this establishment in official correspondence.