Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006615345

FEI Number

3006615345

Entity Name

EIZO GmbH

City/State/Country

Ruelzheim Rhineland-Palatinate, DE

Establishment Address

Carl-Benz-Strasse 3, Ruelzheim Rhineland-Palatinate 76761, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

EIZO GmbH (Owner Number: 10022828)

Owner / Operator Contact Address

Carl-Benz-Strasse 3, Ruelzheim, DE-RP 76761, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

EX5841-KS CuratOR EX5841 CuratOR EX4342 CuratOR EX5542 CuratOR EX4942 CuratOR EX4342-3D TM442

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2012-05-16

Official Correspondent

Anya Caliebe

US Agent Details

Thomas Waletzki Business: EIZO Inc. Email: thomas.waletzki@eizo.com Phone: (562) 4315011

Related Public Records

Same Entity

EIZO GmbH

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006615345. Last updated year: 2026. Please use registration number 3006615345 when referencing this establishment in official correspondence.