Data / Medical devices / Germany / Handelshaus Dittmann GmbH
Handelshaus Dittmann GmbH: FDA-registered device maker in Fuchsstadt Bavaria, Germany, 9 510(k) clearances
Handelshaus Dittmann GmbH is registered with the FDA (registration 3008729899) in Fuchsstadt Bavaria, Germany. It lists 6 device types. The FDA files 9 510(k) clearances under its listings, the newest dated November 22, 2017. Registered through 2026. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3008729899
- Address
- Kissingerstrasse 68, Fuchsstadt Bavaria, Germany, 97727
- Owner or operator
- Handelshaus Dittmann GmbH (10034073)
- Roles
- Repackager or relabeler
- First device listed
- March 6, 2011
- Registered through
- 2026
- Brand names listed
- DITTMANN MEDITEC UG HAFTUNGSBESCHRANKT, Disposable thermometer covers, Ear and Forehead Thermometer, Electrodes TENS Stimulator, MT-402 Flexible Digital Thermometer, Non-Contact Forehead Thermometer TH1009N (KFT509), System Measurement Blood Pressure noninvasive, Tensstimulator TEN603 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | 2 | Repackager or relabeler | accessdata.fda.gov |
| Electrode, Cutaneous | GXY | 2 | Repackager or relabeler | accessdata.fda.gov |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | 2 | Repackager or relabeler | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | 2 | Repackager or relabeler | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Repackager or relabeler | accessdata.fda.gov |
| Thermometer, Clinical Mercury | FLK | 2 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 22, 2017 | K170666 | The Wrist-Type Fully Automatic Digital Blood Pressure Monitors | DXN | Substantially Equivalent | Joytech Healthcare Co. , Ltd. | accessdata.fda.gov |
| November 17, 2016 | K161735 | Non-contact Forehead Thermometer | FLL | Substantially Equivalent | Shenzhen Dongdixin Technology Co., Ltd. | accessdata.fda.gov |
| April 2, 2015 | K150545 | Arm-Type Fully Automatic Digital Blood Pressure Monitor (BP-1305, BP-1307, BP-1326, BP-1318, BP-1319, BP-1211, BP-1312, BSP-11, BSP-12, BSP-13) | DXN | Substantially Equivalent | Sejoy Electronics & Instruments Co., Ltd. | accessdata.fda.gov |
| November 14, 2014 | K141076 | GARMENT ELECTRODES | GXY | Substantially Equivalent | Shenzhen Dongdixin Technology Co., Ltd. | accessdata.fda.gov |
| September 16, 2013 | K130802 | OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060) | NUH | Substantially Equivalent | Shenzhen Dongdixin Technology Co., Ltd. | accessdata.fda.gov |
| July 8, 2013 | K131463 | WRIST AUTOMATIC BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | Honsun (Nantong) Co., Ltd. | accessdata.fda.gov |
| December 16, 2011 | K112289 | DISPOSABLE THERMOMETER COVERS AND SHEATHS | FLL | Substantially Equivalent | Kang ZE Industrial Co. Limited | accessdata.fda.gov |
| July 22, 2010 | K100488 | IR EAR/FOREHEAD THERMOMETER MODE DX6635, DX6637, DTH1081 | FLL | Substantially Equivalent | Shenzhen Dongdixin Technology Co., Ltd. | accessdata.fda.gov |
| May 4, 2007 | K062784 | SEJOY DIGITAL THERMOMETER, MT SERIES (MT-201, MT-301, MT-402, MT-403 AND MT-405) | FLL | Substantially Equivalent | Sejoy Electronics & Instruments Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Continuous Measurement Thermometer
- All makers of Thermometer, Clinical Mercury
- All makers of Stimulator, Muscle, Powered, For Muscle Conditioning
- All makers of Stimulator, Nerve, Transcutaneous, Over-The-Counter
- All makers of Electrode, Cutaneous
Updated November 22, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.