HomeGermanyONDAL MEDICAL SYSTEMS GMBH

ONDAL MEDICAL SYSTEMS GMBH

Germany · Huenfeld Hesse
✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Australia, Israel, Russia — 8 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 3Class II 1Class III 0
plus 8 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class I 1
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
8registered 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 5
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
11active ARTG entries
Class I 9IIb 2
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
6registrations
RURussiaRoszdravnadzor
1active registrations
Class 2a 1
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 States8 registration records, 0 510(k), 0 PMA
Brazil1 confirmed, 0 excluded
Saudi Arabia8 confirmed, 0 excluded
Manufacturer names merged into this page: ONDAL MEDICAL SYSTEMS GMBH · ONDAL MEDICAL SYSTEMS OF AMERICA, INC. · ONDAL MEDICAL SYSTEMS OF AMERICA · Ondal Medical Systems GmbH
Same-named companies — This database also contains companies with near-identical names: ONDAL MEDICAL SYSTEMS OF AMERICA, INC.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Germany
City
Huenfeld Hesse

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 listed device types

Light, Surgical, Ceiling Mounted 1System, Digital Image Communications, Radiological 1Stand, Infusion 1Table, Operating-Room, Ac-Powered 1

Registration details (sample)

MarketIdentifierNameClass / date
BR80753460036Sistema de braço de suporte OrbiterClass I
SAME0000006580SFDAA00007VALiA
SAME0000006580SFDAA00003VALiA

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