Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3031572052

FEI Number

3031572052

Entity Name

CHRISOFIX HUNGARY KFT.

City/State/Country

Budapest, HU

Establishment Address

Grassalkovich ut 272-274., Budapest 1239, HU

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Chrisofix Hungary Kft. (Owner Number: 10090905)

Owner / Operator Contact Address

Grassalkovich ut 272-274., Budapest, HU-BU 1239, HU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Chrisofix rib splint Chrisofix universal resting shell/orthosis for knee Chrisofix universal resting shell/orthosis for foot & ankle - Open heel Chrisofix universal resting shell/orthosis for foot & ankle Chrisofix resting shell/orthosis for lower limb

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IPY	Orthosis, Lumbo-Sacral	Physical Medicine	Class 1	890.3490	2024-05-30
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2024-05-30
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2024-05-30
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2024-05-30

Official Correspondent

Judit Roza

US Agent Details

Melanie Leibowitz Business: Performance Health Supply Email: melanie.leibowitz@performancehealth.com Phone: (331) 6889688

Related Public Records

Same Entity

Chrisofix Hungary Kft.

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 3031572052. Last updated year: 2026. Please use registration number 3031572052 when referencing this establishment in official correspondence.