Data / Medical devices / Germany / Tracoe Medical GMBH
Tracoe Medical GMBH: FDA-registered device maker in NIEDER-OLM Rhineland-Palatinate, Germany, 7 510(k) clearances
Tracoe Medical GMBH is registered with the FDA (registration 8010485) in NIEDER-OLM Rhineland-Palatinate, Germany. It lists 8 device types. The FDA files 7 510(k) clearances under its listings, the newest dated August 5, 2021. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 8010485
- FEI number
- 3003361161
- Address
- Reichelsheimer STR. 1/3, NIEDER-OLM Rhineland-Palatinate, Germany, D-55268
- Owner or operator
- TRACOE MEDICAL GMBH (8010485)
- Roles
- Manufacturer, Specification developer
- First device listed
- January 3, 2003
- Registered through
- 2027
- Brand names listed
- Neck straps, TRACOE HUMID ASSIST, TRACOE PHON ASSIST 1, TRACOE comfort tubes and Accessory, TRACOE experc Dilation Set, TRACOE mini Extension Piece, TRACOE mini tracheostomy tube, TRACOE purofoam and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Condenser, Heat And Moisture (Artificial Nose) | BYD | 1 | Manufacturer | accessdata.fda.gov |
| Connector, Airway (Extension) | BZA | 1 | Manufacturer | accessdata.fda.gov |
| Cuff, Tracheal Tube, Inflatable | BSK | 2 | Manufacturer | accessdata.fda.gov |
| Device, Fixation, Tracheal Tube | CBH | 1 | Specification developer | accessdata.fda.gov |
| Dilator, Tracheal | KCG | 1 | Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Specification developer | accessdata.fda.gov |
| Tube Tracheostomy And Tube Cuff | JOH | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Tube, Tracheostomy (W/Wo Connector) | BTO | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| August 5, 2021 | K203362 | TRACOE vario | JOH | Substantially Equivalent | Tracoe Medical GmbH | accessdata.fda.gov |
| April 27, 2018 | K172720 | TRACOE silcosoft Tracheostomy Tube | JOH | Substantially Equivalent | Tracoe Medical GmbH | accessdata.fda.gov |
| September 27, 2016 | K152865 | TRACOE smart Cuff Manager | BSK | Substantially Equivalent | Tracoe Medical GmbH | accessdata.fda.gov |
| February 18, 2005 | K043160 | TRACOE PHON ASSIST I - SPEAKING VALVES, REFERENCE MODELS: PHON ASSIST I-650-T/TO AND 650-S/SO | JOH | Substantially Equivalent | Tracoe Medical GmbH | accessdata.fda.gov |
| September 13, 1996 | K961449 | TRACHEOSTOMY TUBES TRACOE-FLEX | JOH | Substantially Equivalent | Tracoe Medical GmbH | accessdata.fda.gov |
| August 7, 1989 | K893866 | HOOD PEDIATRIC TRACHEOSTOMY TUBE | BTO | Substantially Equivalent | Hood Laboratories | accessdata.fda.gov |
| October 24, 1978 | K781729 | TRACHEOTOMY TUBES | BTO | Substantially Equivalent | Tracoe Medical GmbH | accessdata.fda.gov |
Compare with other makers
- All makers of Cuff, Tracheal Tube, Inflatable
- All makers of Connector, Airway (Extension)
- All makers of Tube Tracheostomy And Tube Cuff
- All makers of Condenser, Heat And Moisture (Artificial Nose)
- All makers of Device, Fixation, Tracheal Tube
- All makers of Dressing, Wound, Occlusive
Updated August 5, 2021. 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.