HomeGermanyFUJIFILM medwork GmbH

FUJIFILM medwork GmbH

Germany · Hochstadt/Aisch Bavaria
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Taiwan, Singapore, South Korea, Australia, Israel — 7 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
3listed device types
Class I 1Class II 2Class III 0
plus 2 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
25registered devices
Class II 25
28 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
2valid device licences
Class II 2
SGSingaporeHSA SMDR
9device registrations
CLASS B 7CLASS C 2
KRSouth KoreaMFDS GMP
2GMP quality-system certificates
Import 2
AUAustraliaTGA ARTG
8active ARTG entries
IIa 2IIb 2Class Is (sterile) 4
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
6registrations
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 States2 registration records, 2 510(k), 0 PMA
Brazil25 confirmed, 3 excluded
Canada0 confirmed, 1 excluded
Manufacturer names merged into this page: FUJIFILM medwork GmbH · FUJIFILM MEDWORK GMBH

Company information

Country
Germany
City
Hochstadt/Aisch Bavaria

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

12021 · K210625
12022 · K221264

FDA listed device types

Endoscope Channel Accessory 1Colonoscope And Accessories, Flexible/Rigid 1Adaptor, Catheter 1

Registration details (sample)

MarketIdentifierNameClass / date
USK221264FROG Forceps Valve (VAL1-F1-100)2022-06-01
USK210625JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve2021-09-10
BR80022069058Agulha para Ecoendoscopia EUS1-A1-25 e EUS1-B1-25Class II
BR80022069059Agulha para Ecoendoscopia EUS1-A1-19Class II
BR80022069060Agulha para Ecoendoscopia EUS1Class II

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