HomeGermanyOCULUS OPTIKGERATE GMBH

OCULUS OPTIKGERATE GMBH

Germany · Wetzlar Hesse
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Taiwan, South Korea, Australia, Hong Kong, 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
23listed device types
Class I 19Class II 4Class III 0
plus 25 registration records and 6 510(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
16valid device licences
Class I 10Class II 6
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
11active ARTG entries
Class I 6IIa 2Class Im (measuring) 1Class Is (sterile) 2
HKHong KongMDACS
1valid listings
Class II 1
ILIsraelAMAR
6registrations
RURussiaRoszdravnadzor
15active registrations
Class 1 6Class 2a 9
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 States25 registration records, 6 510(k), 0 PMA
Manufacturer names merged into this page: OCULUS OPTIKGERATE GMBH

Company information

Country
Germany
City
Wetzlar 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 510(k) clearances by year

12003 · K030719
12005 · K041841
12008 · K073508
12012 · K113066
12016 · K152311
12020 · K201724

FDA listed device types

showing 8 of 23
Tonometer, Ac-Powered 1Tomography, Optical Coherence 1Biomicroscope, Slit-Lamp, Ac-Powered 1Device, Analysis, Anterior Segment 1Set, Lens, Trial, Ophthalmic 1Spectacle, Magnifying 1Topographer, Corneal, Ac-Powered 1Frame, Trial, Ophthalmic 1

Registration details (sample)

MarketIdentifierNameClass / date
USK201724Pentacam AXL Wave2020-10-21
USK152311Pentacam AXL2016-01-20
USK113066CORVIS ST2012-11-08

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