Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008729899

FEI Number

3008729899

Entity Name

Handelshaus Dittmann GmbH

City/State/Country

Fuchsstadt Bavaria, DE

Establishment Address

Kissingerstrasse 68, Fuchsstadt Bavaria 97727, DE

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Handelshaus Dittmann GmbH (Owner Number: 10034073)

Owner / Operator Contact Address

Kissinger Strasse 68, Fuchsstadt, DE-BY 97727, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K112289

PMA Number

N/A

All Registered Proprietary Names

Electrodes TENS Stimulator MT-402 Flexible Digital Thermometer Tensstimulator TEN603 DITTMANN MEDITEC UG HAFTUNGSBESCHRANKT Ear and Forehead Thermometer Wrist Blood Pressure Monitor Disposable thermometer covers

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2017-12-17
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2016-03-13
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2017-12-15
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2017-12-15
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2011-03-06
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2019-02-15
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2017-03-31
FLK	Thermometer, Clinical Mercury	General Hospital	Class 2	880.2920	2017-03-31

Official Correspondent

Heike Karl

US Agent Details

Martina Williams Business: Greater Concepts by Design Email: greaterconcepts@live.com Phone: (815) 3429554

Related Public Records

Same Entity

Handelshaus Dittmann 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
K070612	Top-Rank Health Care Equipment Co., Ltd.	TOP-RANK ADHESIVE ELECTRODE	2007-05-07
K123915	Grass Technologies, an Astro-Med, Inc. Product Gro	DE48-PLUS	2013-04-24
K073532	Technomed Europe	DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES	2008-05-01
K260363	Ceribell, Inc.	Ceribell Brain Monitor Headband	2026-04-03
K091762	Covidien	DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE	2009-12-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0032-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.

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3005581220	SPES MEDICA S.P.A	BATTIPAGLIA Salerno, IT
9616086	DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.	TIJUANA Baja California, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008729899. Last updated year: 2026. Please use registration number 3008729899 when referencing this establishment in official correspondence.