HomeGermanyTECHNOLAS PERFECT VISION GMBH

TECHNOLAS PERFECT VISION GMBH

Germany · Munich
✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Hong Kong, Israel, Russia — 9 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
5listed device types
Class I 2Class II 2Class III 1
plus 8 registration records and 10 510(k), 25 PMA
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class II 2
3 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
6active device licences
Class II 3Class III 3
11 including historic records
TWTaiwanTFDA
5valid device licences
Class I 1Class II 3Class III 1
SGSingaporeHSA SMDR
1device registrations
CLASS C 1
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
2valid listings
Class III 2
ILIsraelAMAR
2registrations
RURussiaRoszdravnadzor
9active registrations
Class 1 1Class 2a 1Class 2b 7
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, 10 510(k), 25 PMA
Brazil2 confirmed, 0 excluded
Canada6 confirmed, 0 excluded
Manufacturer names merged into this page: TECHNOLAS PERFECT VISION GMBH

Company information

Country
Germany
City
Munich

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

11999
12011
12012
12013
22014
22015
12017
12020

FDA listed device types

Unit, Phacofragmentation 1Ophthalmic Femtosecond Laser 1Aberrometer, Ophthalmic 1Keratome, Ac-Powered 1Excimer Laser System 1

Registration details (sample)

MarketIdentifierNameClass / date
USK200724VICTUS Femtosecond Laser Platform2020-09-01
USK171014VICTUS Femtosecond Laser Platform2017-10-19
USK151161VICTUS Femtosecond Laser Platform2015-06-24
BR80628810001INTERFACE KIT - 520FClass II
BR80628810004KIT INTERFACE DO PACIENTE PARA CATARATAClass II
CA65191MICROKERATOME DISPOSABLE BLADESClass II
CA67059ZYOPTIX XP MICROKERATOME SYSTEMClass II
CA80510ZYOPTIX TREATMENT CALCULATOR SOFTWAREClass III

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