HomeHaag-Streit Surgical GmbH & Co. KG

Haag-Streit Surgical GmbH & Co. KG

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Russia — 6 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
21listed device types
Class I 16Class II 5Class III 0
plus 25 registration records and 6 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
12registered devices
Class I 2Class II 10
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
13registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
17 including historic records
TWTaiwanTFDA
1valid device licences
Class I 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
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 States25 registration records, 6 510(k), 0 PMA, 1 excluded
Brazil12 confirmed, 0 excluded
Saudi Arabia13 confirmed, 0 excluded
Manufacturer names merged into this page: HAAG-STREIT USA, INC. · HAAG-STREIT AG · Haag-Streit Deutschland GmbH · HAAG-STREIT UK LTD. · HAAG-STREIT, AG · HAAG STREIT UK LTD
Same-named companies — This database also contains companies with near-identical names: Haag-Streit Holding AG, Haag-Streit Deutschland GmbH, HAAG-STREIT UK LTD., HAAG-STREIT USA, INC.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

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

11998 · K982057
12003 · K030393
12005 · K051103
12009 · K082891
12010 · K100202
12014 · K142423

FDA listed device types

showing 8 of 21
Instrument, Ent Manual Surgical 1Chart, Visual Acuity 1Chair, Ophthalmic, Manual 1Strip, Schirmer 1Chair, Ophthalmic, Ac-Powered 1Refractor, Manual, Non-Powered, Including Phoropter 1Unit, Examining/Treatment, Ent 1Instrument, Measuring, Stereopsis 1

Registration details (sample)

MarketIdentifierNameClass / date
USK142423EyeSuite Imaging2014-09-10
USK100202SLIT LAMP BO 900, BQ 900, BP9002010-03-19
USK082891LENSTAR, MODEL LS9002009-10-20
BR80102519440Lâmpada de fenda - Elara 900Class II
BR80170280054LÂMPADA DE FENDA HAAG - STREITClass I
BR80102511436Perímetro OctopusClass II
SAME0000018994SFDAA00001HS ALLERGA 90
SAME0000018995SFDAA00001HS Hi-R NEO 900

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