HomeGermanyOptomedical Technologies GmbH

Optomedical Technologies GmbH

Germany · Luebeck
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Taiwan — 2 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
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
1valid device licences
Class II 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
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 States0 registration records, 2 510(k), 0 PMA

Company information

Country
Germany
City
Luebeck

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

12015 · K142953
12020 · K200516

Registration details (sample)

MarketIdentifierNameClass / date
USK200516OCT-Camera ID 21101A32020-09-02
USK142953OCT-Camera2015-03-04

Similar companies

1st German Health Resilience Conference
Germany · markets 0
3B Scientific GmbH
Germany · markets 1
3R LifeScience GmbH
Germany · markets 0
6th International Sports Pharmacy Symposium
Germany · markets 0
A&D Verpackungsmaschinenbau GmbH
Germany · markets 0
A. u. K. Müller GmbH & Co. KG
Germany · markets 0
Is this your company? Claim the page, add information or report a data error.Claim / report an error →