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Ge Hungary Kft

Hungary · Budapest

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Singapore, Israel — 5 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

39listed device types

Class I 22Class II 15Class III 0unclassified 2

plus 64 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

14registered devices

Class I 12Class II 2

15 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

1active device licences

Class II 1

3 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

3device registrations

CLASS B 1CLASS C 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States64 registration records, 5 510(k), 0 PMA, 3 excluded

Brazil14 confirmed, 0 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: CHRISOFIX HUNGARY KFT. · Coloplast Hungary, KFT · Varian Medical Systems Hungary Kft. · GREINER BIO-ONE HUNGARY KFT · GE HUNGARY KFT · SAFEGARD MEDICAL (HUNGARY) KFT.

Same-named companies — This database also contains companies with near-identical names: GREINER BIO-ONE HUNGARY KFT, Varian Medical Systems Hungary Kft.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

12013 · K132045

12014 · K132944

12019 · K190038

12023 · K221200

12025 · K242926

FDA listed device types

showing 8 of 39

Container, Specimen, Sterile 1Scissors, Medical, Disposable 1Solvent, Adhesive Tape 1Splint, Hand, And Components 1Dressing, Wound, Occlusive 1Catheter, Continuous Irrigation 1Orthosis, Limb Brace 1Device, Incontinence, Urosheath Type, Non-Sterile 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K242926	XBody Go USA, XBody Pro USA	2025-05-30
US	K221200	XBody Go USA, XBody Pro USA	2023-01-31
US	K190038	Xbody Newave USA	2019-04-05
BR	10430310015	COMFEEL PLUS CURATIVO DE CONTORNO	Class II
BR	10430310017	COMFEEL PLUS CURATIVO ALIVIADOR DE PRESSAO	Class II
BR	10430319015	MC 2000 SISTEMA DE UMA PECA PARA OSTOMIA COLOPLAST	Class I
CA	92143	SECUREGARD RETRACTABLE SAFETY SYRINGE (WITH NEEDLE)	Class II

Ge Hungary Kft

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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