Data / Medical devices / Switzerland / Haag-Streit AG

Haag-Streit AG: FDA-registered device maker in KOENIZ Bern, Switzerland, 5 510(k) clearances

Name: Haag-Streit AG FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Haag-Streit AG is registered with the FDA (registration 1000176188) in KOENIZ Bern, Switzerland. It lists 10 device types. The FDA files 5 510(k) clearances under its listings, the newest dated September 10, 2014. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 1000176188
Address: Gartenstadtstrasse 10, KOENIZ Bern, Switzerland, CH-3098
Owner or operator: HAAG-STREIT HOLDING (8031066)
Roles: Exporter to the US, Manufacturer
First device listed: April 25, 1978
Registered through: 2027
Brand names listed: APPLANATION TONOMETER AT 870, APPLANATION TONOMETER AT 900 BQ, APPLANATION TONOMETER AT 900 R, APPLANATION TONOMETER AT 900 T, Accessory, C.MOR HD; C.MOR HD ³, Elara 900, Elara 900 VS and more

Devices it lists

Device	Product code	Class	Role	Source
Biomicroscope, Slit-Lamp, Ac-Powered	HJO	2	Manufacturer	accessdata.fda.gov
Biomicroscope, Slit-Lamp, Ac-Powered, Exempt	PUE	2	Manufacturer	accessdata.fda.gov
Camera, Surgical And Accessories	KQM	1	Manufacturer	accessdata.fda.gov
Device, Storage, Images, Ophthalmic	NFF	1	Manufacturer	accessdata.fda.gov
Lens, Contact, Polymethylmethacrylate, Diagnostic	HJK	2	Manufacturer	accessdata.fda.gov
Microscope, Operating & Accessories, Ac-Powered, Ophthalmic	HRM	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Perimeter, Automatic, Ac-Powered	HPT	1	Manufacturer	accessdata.fda.gov
Refractor, Manual, Non-Powered, Including Phoropter	HKN	1	Manufacturer	accessdata.fda.gov
System, Image Management, Ophthalmic	NFJ	2	Manufacturer	accessdata.fda.gov
Tonometer, Manual	HKY	2	Exporter to the US, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 10, 2014	K142423	EyeSuite Imaging	NFJ	Substantially Equivalent	Haag-Streit AG	accessdata.fda.gov
October 20, 2009	K082891	LENSTAR, MODEL LS900	HJO	Substantially Equivalent	Haag-Streit AG	accessdata.fda.gov
June 7, 2005	K051103	HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORY	HJK	Substantially Equivalent	Haag-Streit USA, Inc.	accessdata.fda.gov
January 12, 1999	K981432	GOLDMAN MANUAL TONOMETER	HKY	Substantially Equivalent	Golden Vision, Inc.	accessdata.fda.gov
July 18, 1996	K961512	PERKINS HAND-HELD APPLANATION TONOMETER	HKY	Substantially Equivalent	Clement Clarke, Inc.	accessdata.fda.gov

Compare with other makers

Updated September 10, 2014. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.