HomeGermanyERGOLINE GMBH

ERGOLINE GMBH

Germany · Bitz
✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, 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
4listed device types
Class I 2Class II 2Class III 0
plus 4 registration records and 3 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class II 1
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
1registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
1 including historic records
TWTaiwanTFDA
5valid device licences
Class I 1Class II 4
SGSingaporeHSA SMDR
1device registrations
CLASS B 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
6active ARTG entries
Class I 2IIa 3Class Im (measuring) 1
HKHong KongMDACS
5valid listings
Class II 5
ILIsraelAMAR
7registrations
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 States4 registration records, 3 510(k), 0 PMA
Brazil1 confirmed, 0 excluded
Saudi Arabia1 confirmed, 0 excluded
Manufacturer names merged into this page: ERGOLINE GMBH · ergoline GmbH

Company information

Country
Germany
City
Bitz

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

12006 · K053078
12012 · K112121
12022 · K212883

FDA listed device types

Exerciser, Measuring 1Transmitters And Receivers, Physiological Signal, Radiofrequency 1Operating Room Accessories Table Tray 1Treadmill, Powered 1

Registration details (sample)

MarketIdentifierNameClass / date
USK212883ers2 - ergoline Rehabilitation System2022-07-15
USK112121ERGOSELECT/GE2012-10-31
USK053078ERGOSELECT 100 K/P, ERGOSELECT 200 K/P2006-04-27
BR81895419023ergoselect 1Class II
SAME0000005028SFDAA00026Ergocar PC 4

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