HomeGermanyBarkey GmbH & Co. KG

Barkey GmbH & Co. KG

Germany · Leopoldshohe
✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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
2510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
3registered devices
Class I 3
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
1 including historic records
TWTaiwanTFDA
3valid device licences
Class II 3
SGSingaporeHSA SMDR
3device registrations
CLASS C 3
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
4active ARTG entries
IIa 2IIb 2
HKHong KongMDACS
1valid listings
Class III 1
ILIsraelAMAR
8registrations
RURussiaRoszdravnadzor
2active registrations
Class 2a 2
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 States0 registration records, 2 510(k), 0 PMA
Brazil3 confirmed, 0 excluded
Manufacturer names merged into this page: BARKEY GMBH & CO. KG

Company information

Country
Germany
City
Leopoldshohe

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

12007 · K071909
12022 · K213191

Registration details (sample)

MarketIdentifierNameClass / date
USK213191S-Line2022-05-24
USK071909PRISMACOMFORT, MODEL AUTOCONTROL 3XPT WITH AUTOLINE XPT 4R2007-10-18
BR80125859006BARKEY PLASMATHERMClass I
BR80832339006BARKEY PLASMATHERMClass I
BR80125859007BARKEY S-LINEClass I

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