Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004950803

FEI Number

3004950803

Entity Name

HAAG-STREIT UK LTD.

City/State/Country

Bishop's Stortford Hertfordshire, GB

Establishment Address

Unit C, Woodside, Woodside Industrial Estate, Dunmow Road, Bishop's Stortford Hertfordshire CM23 5RG, GB

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,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

John Weiss Reusable Instrument SCHIRMER TEAR TEST FRISBY STEREOTEST LANG STEREO TEST CAT STEROGRAMS TNO STEREO TEST VARIOUS STERO TEST OPEN BUCKET STEREOGRAMS 123 STEREOGRAMS PER PKT 0F 100 CAT STEREOGRAMES TNO STEREOTEST C/W SPECTACLES FRISBY STEREOTEST LANG STEREOTEST NO.1 IN WALLET John Weiss Reusable Instrument CAMBRIDGE L/C SENSITIVITY GRTG TRAQUAIR TARGETS BAILEY-LOVIE WORD READING CHRT SHERIDAN GARDINER, COMP SET VOCATIONAL NVTT(VAT ZERO RATE) NEAR VISION TEST VARIOUS CAMBRIDGE CROWDING CARDS,COMP KAY FIXATION

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2005-02-10
KYD	Strip, Schirmer	Ophthalmic	Class 1	886.1800	2005-01-12
HLP	Target, Fusion And Stereoscopic	Ophthalmic	Class 1	886.1880	2005-01-12
HKY	Tonometer, Manual	Ophthalmic	Class 2	886.1930	2007-12-12
HLC	Instrument, Measuring, Stereopsis	Ophthalmic	Class 1	886.1460	1994-09-13
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	1998-08-05
HOX	Chart, Visual Acuity	Ophthalmic	Class 1	886.1150	1994-09-13

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
1000176188	HAAG-STREIT AG	KOENIZ Bern, CH

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K143738	Intuit Medical Products, LLC	DSS Sinusplasty Balloon Catheter	2015-08-27

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004950803. Last updated year: 2026. Please use registration number 3004950803 when referencing this establishment in official correspondence.