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Home›Hungary›GREINER BIO-ONE HUNGARY KFT

GREINER BIO-ONE HUNGARY KFT

Hungary · Mosonmagyarovar Gy?R-Moson-Sopron
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
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: Ge Hungary Kft, Varian Medical Systems Hungary Kft.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Hungary
City
Mosonmagyarovar Gy?R-Moson-Sopron

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

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)

MarketIdentifierNameClass / date
USK242926XBody Go USA, XBody Pro USA2025-05-30
USK221200XBody Go USA, XBody Pro USA2023-01-31
USK190038Xbody Newave USA2019-04-05
BR10430310015COMFEEL PLUS CURATIVO DE CONTORNOClass II
BR10430310017COMFEEL PLUS CURATIVO ALIVIADOR DE PRESSAOClass II
BR10430319015MC 2000 SISTEMA DE UMA PECA PARA OSTOMIA COLOPLASTClass I
CA92143SECUREGARD RETRACTABLE SAFETY SYRINGE (WITH NEEDLE)Class II

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