HomeGermanyGANSHORN MEDIZIN ELECTRONIC GMBH

GANSHORN MEDIZIN ELECTRONIC GMBH

Germany · Bad Neustadt Bavaria
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Taiwan, Singapore, South Korea, Australia, Israel, Russia — 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
4listed device types
Class I 1Class II 3Class III 0
plus 3 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
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
TWTaiwanTFDA
2valid device licences
Class II 2
SGSingaporeHSA SMDR
5device registrations
CLASS B 5
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
1active ARTG entries
IIa 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
3registrations
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 States3 registration records, 2 510(k), 0 PMA
Manufacturer names merged into this page: GANSHORN MEDIZIN ELECTRONIC GMBH

Company information

Country
Germany
City
Bad Neustadt 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

12016 · K160116
12024 · K240706

FDA listed device types

Filter, Bacterial, Breathing-Circuit 1Spirometer, Diagnostic 1Plethysmograph, Volume 1Mouthpiece, Breathing 1

Registration details (sample)

MarketIdentifierNameClass / date
USK240706PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+)2024-12-09
USK160116SpiroScout2016-10-07

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