Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015280549

FEI Number

3015280549

Entity Name

GOOD MEDICA SP.ZO.O.

City/State/Country

Wroclaw Dolnoslaskie, PL

Establishment Address

ul.Ziemniaczana 15,52-127 Wroclaw, Wroclaw Dolnoslaskie 52127, PL

Establishment Type(s)

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

Owner / Operator

Good Medica sp.zo.o. (Owner Number: 10059976)

Owner / Operator Contact Address

ul.Ziemniaczana 15,52-127 Wroclaw, Wroclaw, PL-NOTA 52127, PL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Reusable Tourniquet Cuff, Reusable Conical Cuff Automatic Tourniquet System Tourniquet, Pneumatic - Disposable Conical Cuff, Disposable Tourniquet Cuff, Instrument, Cast Removal, Ac-Powered - Medical Electric Plaster Saw Exerciser, Powered-CPM

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KCY	Tourniquet, Pneumatic	General, Plastic Surgery	Class 1	878.5910	2019-03-17
LGH	Instrument, Cast Removal, Ac-Powered	Orthopedic	Class 1	888.5960	2019-03-17
BXB	Exerciser, Powered	Physical Medicine	Class 1	890.5380	2019-03-17

Official Correspondent

Fudalej Piotr

US Agent Details

Jimmy Chen Business: Hyun Turle E-Commerce Inc Email: Kin.grace@hotmail.com Phone: (626) 6273399

Related Public Records

Same Entity

Good Medica sp.zo.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 3015280549. Last updated year: 2026. Please use registration number 3015280549 when referencing this establishment in official correspondence.