Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1223498

FEI Number

1000136533

Entity Name

HAAG-STREIT USA, INC.

City/State/Country

MASON, OH, US

Establishment Address

3535 Kings Mills Rd, MASON, OH 45040, US

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

522V XOMA Tower/Stand FX520 710 Premiere 7000 Premiere 981 FXM-920 6200 940 (Chair Mover) 7296 (Chair Glide Extended) 7000 7295 (Chair Glide) 2000 710 980 FX920 520 942 (Chair Mover) 1590 1490 5400 I-OPS 1390 5410 I-OPS 314990 Footswitch Adapter 7200 7900 1700 7000 1701 7400 7900V 1690 310 410 510 610

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HME	Chair, Ophthalmic, Ac-Powered	Ophthalmic	Class 1	886.1140	1994-03-28
HMF	Stand, Instrument, Ac-Powered, Ophthalmic	Ophthalmic	Class 1	886.1860	1994-08-18
ETF	Unit, Examining/Treatment, Ent	Ear, Nose, Throat	Class 1	874.5300	1994-06-30

Official Correspondent

Thomas Diesch

US Agent Details

No US Agent registered (Local establishment).

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
3004950803	HAAG-STREIT UK LTD.	Bishop's Stortford Hertfordshire, GB
1000176188	HAAG-STREIT AG	KOENIZ Bern, CH

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1223498. Last updated year: 2026. Please use registration number 1223498 when referencing this establishment in official correspondence.