Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8010617

FEI Number

6062

Entity Name

HEINZ KURZ GMBH MEDIZINTECHNIK

City/State/Country

DUSSLINGEN Baden-Wurttemberg, DE

Establishment Address

TUEBINGER STRASSE 3, DUSSLINGEN Baden-Wurttemberg D-72144, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

HEINZ KURZ GMBH (Owner Number: 8010617)

Owner / Operator Contact Address

TUEBINGER STRASSE 3, DUSSLINGEN, DE-BW D-72144, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CliP Piston MVP Stapes Prosthesis KURZ Upper Eyelid Implant (Platin/Iridium) Omega Connector TTP-VARIAO AERIAL Total Prosthesis TTP-VARIAC System Total TTP-VARIAC System Partial TTP-VARIO BELL Partial Prosthesis Minimal Type Ventilation Tubes Tuebingen Type Ventilation Tubes Ventilation Tubes with Eyelets / Long-term Beveled Type Ventilation Tubes CliP Piston aWengen Soft CliP Piston SoftCliP Hook Trocar Handle KURZ Cartilage Punch "Huettenbrink" Titanium Micro Closing Forceps Micro Scissors Cutting Forceps KURZ Precise Cartilage Cutter Duesseldorf Type AERIAL Total Prosthesis TTP-Tuebingen AERIAL Total Prosthesis Malleus Notch Prosthesis (MNP) Total Regensburg Type Prosthesis NITIBOND Stapes Prosthesis CliP Partial FlexiBAL CliP Partial Prosthesis Dresden Type KURZ Upper Eyelid Implant Sizers (Test weight set Upper Eyelid Implants) Skrzynski Stapes Prosthesis MatriX Stapes Prosthesis NITIFLEX Stapes Prosthesis Bucket Type Stapes Prosthesis MatriX Offset Stapes Prosthesis MatriX SlimLine Stapes Prosthesis KURZ Meter Sizer Omega Connector AC Sizer System Partial AC Sizer System Total Trocar Ventilation Tube (TVT) Tray KURZ Meter Tray Cartilage Punch Tray TTP-VARIAC

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ETA	Replacement, Ossicular Prosthesis, Total	Ear, Nose, Throat	Class 2	874.3495	2007-11-10
MML	Weights, Eyelid, External	Ophthalmic	Class 2	886.5700	2007-11-10
ETB	Prosthesis, Partial Ossicular Replacement	Ear, Nose, Throat	Class 2	874.3450	2007-11-10
ETA	Replacement, Ossicular Prosthesis, Total	Ear, Nose, Throat	Class 2	874.3495	2007-11-10
ETD	Tube, Tympanostomy	Ear, Nose, Throat	Class 2	874.3880	2007-11-10
ETB	Prosthesis, Partial Ossicular Replacement	Ear, Nose, Throat	Class 2	874.3450	2007-11-10
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2003-08-01
NNS	Instrument, Prosthesis Modification For Ossicular Replacement Surgery, Non-Sterile	Ear, Nose, Throat	Class 1	874.3540	2007-11-10
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	1997-09-08
ETA	Replacement, Ossicular Prosthesis, Total	Ear, Nose, Throat	Class 2	874.3495	2007-11-10
ETB	Prosthesis, Partial Ossicular Replacement	Ear, Nose, Throat	Class 2	874.3450	2013-03-12
ETB	Prosthesis, Partial Ossicular Replacement	Ear, Nose, Throat	Class 2	874.3450	2007-11-10
MML	Weights, Eyelid, External	Ophthalmic	Class 2	886.5700	2007-11-10
ETB	Prosthesis, Partial Ossicular Replacement	Ear, Nose, Throat	Class 2	874.3450	2013-12-16
JYJ	Gauge, Measuring	Ear, Nose, Throat	Class 1	874.4420	1997-09-08
ETD	Tube, Tympanostomy	Ear, Nose, Throat	Class 2	874.3880	2007-12-13
MMO	Tray, Surgical, Ent	Ear, Nose, Throat	Class 1	874.4420	2005-09-22

Official Correspondent

Marcus A. Eisenhut

US Agent Details

Stuart Montgomery Business: Kurz Medical Inc. Email: smontgomery@bosmed.com Phone: (508) 8989300

Related Public Records

Same Entity

HEINZ KURZ GMBH

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

View Entity Profile →

Related 510(k) Records

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

Similar Registrations

Registration Number	Establishment Name	Location
3009217531	Eurofins STERIPAC GMBH	Calw-Altburg Baden-Wurttemberg, DE
9612501	Covidien	- Santo Domingo, DO
3011050570	Gyrus ACMI, Inc.	Brooklyn Park, MN, US
3018094310	Medtronic Engineering and Innovation Center (MEIC)	Hyderabad Telangana, IN
3003790304	GYRUS ACMI, INC.	Westborough, MA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010617. Last updated year: 2026. Please use registration number 8010617 when referencing this establishment in official correspondence.