Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1000176188

FEI Number

1000176188

Entity Name

HAAG-STREIT AG

City/State/Country

KOENIZ Bern, CH

Establishment Address

GARTENSTADTSTRASSE 10, KOENIZ Bern CH-3098, CH

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

HAAG-STREIT HOLDING (Owner Number: 8031066)

Owner / Operator Contact Address

GARTENSTADTSTRASSE 10, --, KOENIZ, CH-BE CH-3098, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

HS Surgical Microscopes, Carrier and Accessories: Hi-R NEO 900(;900A) / FS 2-25 / Accessories Metis 900 Metis 3D Digital Heads-Up Module HS MIOS 5 Stery Cup Accessory Haag-Streit Contact Glasses HS Surgical Microscopes, Carrier and Accessories: Hi-R NEO 900(;900A) / FS 2-25 / Accessories Metis 900 Metis 3D Digital Heads-Up Module Lenstar Myopia APS EyeSuite Myopia + AMMC Software EyeSuite Myopia Standalone Eyesuite Myopia Phoropter Refractor 900 Prism Phoropter Refractor 900 C.MOR HD; C.MOR HD ³

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HRM	Microscope, Operating & Accessories, Ac-Powered, Ophthalmic	General, Plastic Surgery	Class 1	878.4700	1978-04-25
HPT	Perimeter, Automatic, Ac-Powered	Ophthalmic	Class 1	886.1605	2003-12-26
NFF	Device, Storage, Images, Ophthalmic	Radiology	Class 1	892.2010	2012-12-03
HJK	Lens, Contact, Polymethylmethacrylate, Diagnostic	Ophthalmic	Class 2	886.1385	2011-03-29
HRM	Microscope, Operating & Accessories, Ac-Powered, Ophthalmic	General, Plastic Surgery	Class 1	878.4700	1978-04-25
HJO	Biomicroscope, Slit-Lamp, Ac-Powered	Ophthalmic	Class 2	886.1850	2009-11-03
HKY	Tonometer, Manual	Ophthalmic	Class 2	886.1930	2007-12-12
NFJ	System, Image Management, Ophthalmic	Radiology	Class 2	892.2050	2014-10-28
HKN	Refractor, Manual, Non-Powered, Including Phoropter	Ophthalmic	Class 1	886.1770	1997-07-24
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2014-12-16

Official Correspondent

Thomas Diesch

US Agent Details

Thomas Diesch Email: regulatory@haag-streit.com Phone: (800) 7875426

Related Public Records

Same Entity

HAAG-STREIT HOLDING

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3010183984	Haag-Streit Deutschland GmbH	WEDEL Schleswig-Holstein, DE
3015399802	HS DOMS GMBH	Saalfeld Thuringia, DE
1223498	HAAG-STREIT USA, INC.	MASON, OH, US
3004950803	HAAG-STREIT UK LTD.	Bishop's Stortford Hertfordshire, GB

Similar Registrations

Registration Number	Establishment Name	Location
3021656770	UPT OPTIK WODAK GMBH	Nuernberg Bavaria, DE
1037885	ADVANCE MEDICAL DESIGNS, INC.	MARIETTA, GA, US
9612297	INAMI & CO., LTD.	Bunkyo Tokyo, JP
3005527296	LABOTECH MICROSCOPES INDIA PRIVATE LIMITED	AMBALA CANTT Haryana, IN
9611269	OCULUS OPTIKGERATE GMBH	WETZLAR Hesse, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000176188. Last updated year: 2026. Please use registration number 1000176188 when referencing this establishment in official correspondence.