This page includes the latest FDA filings for Tracoe Medical G M B H. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 8010485 |
| FEI Number | 3003361161 |
| Name | Lu Anne Bauer |
| Owner & Operator | TRACOE MEDICAL GMBH |
| Contact Address | Reichelsheimer Str. 1/3 -- Nieder-Olm DE-RP Rheinland-Pfalz 55268 DE |
| Official Correspondent |
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| US Agent |
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| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 14 E Eau Claire St Unit 447 Rice Lake, WI 54868 US |
| Establishment Type |
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Device Company | Device | Date |
|---|---|---|
| Tracoe medical GmbH | TRACOE care REF 909 | 2025-01-21 |
| Tracoe medical GmbH | TRACOE care REF 908 | 2025-01-21 |
| Tracoe medical GmbH | TRACOE mini REF 356 | 2025-01-21 |
| Tracoe medical GmbH | TRACOE care REF 907-B | 2025-01-21 |
| Tracoe medical GmbH | TRACOE care REF 903-B-P | 2024-12-12 |
| Tracoe medical GmbH | TRACOE mini REF 355-4.5 | 2024-11-29 |
| Tracoe medical GmbH | TRACOE mini REF 355-4.0 | 2024-11-29 |
| Tracoe medical GmbH | TRACOE mini REF 355-3.5 | 2024-11-29 |
| Tracoe medical GmbH | TRACOE mini REF 355-3.0 | 2024-11-29 |
| Tracoe medical GmbH | TRACOE mini REF 355-2.5 | 2024-11-29 |
| Tracoe medical GmbH | TRACOE mini REF 350-4.0 | 2024-11-29 |
| Tracoe medical GmbH | TRACOE mini REF 350-3.5 | 2024-11-29 |
| Tracoe medical GmbH | TRACOE mini REF 350-3.0 | 2024-11-29 |
| Tracoe medical GmbH | TRACOE mini REF 350-2.5 | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 104-11A-N | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 103-11A | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 103-10A | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 103-09A | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 103-08A | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 103-07A | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 103-06A | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 104-11A | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 104-11 | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 104-10N | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 104-10A-N | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 104-10A | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 204-12A-N | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 104-10 | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 204-11A-N | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 204-06A-N | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 204-05A-N | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 204-05 | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 104-09N | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 104-09A-N | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 104-09A | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 105-12-1D | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 105-11-1D | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 105-10-1D | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 105-09-1D | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 104-09 | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 105-08-1D | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 105-07-1D | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 104-08N | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 105-06-1D | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 104-08A-N | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 104-08A | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 105-05-1D | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 104-08 | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 104-07N | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 104-07A-N | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 104-07A | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 104-07 | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 104-06N | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 104-06A-N | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 104-06A | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 104-06 | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 104-05N | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 104-05A-N | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 104-05A | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 104-05 | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 103-12N | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 103-12 | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 103-11N | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 103-11 | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 103-10N | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 103-10 | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 103-09N | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 103-09 | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 103-08N | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 103-08 | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 103-07N | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 103-07 | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 103-06N | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 103-06 | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 103-05N | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 103-05 | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 102-12D | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 102-12 | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 102-11D | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 102-11 | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 102-10D | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 102-10 | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 102-09D | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 102-09 | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 102-08D | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 102-08 | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 102-07D | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 102-07 | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 102-06D | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 102-06 | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 102-05D | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 102-05 | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 101-12 | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 101-11 | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 101-10 | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 101-09 | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 101-08 | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 101-07 | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 101-06 | 2024-11-29 |
| Tracoe medical GmbH | TRACOE comfort REF 101-05 | 2024-11-29 |
TRACOE Medical GmbH | TRACOE Vario | 2021-08-05 |
Lu Anne Bauer [TRACOE MEDICAL GMBH] | Adhesive Carrier | 2019-12-20 |
Lu Anne Bauer [TRACOE MEDICAL GMBH] | Tracheal Compresses | 2019-12-20 |
Lu Anne Bauer [TRACOE MEDICAL GMBH] | TRACOE silcosoft Tracheostomy Tube | 2018-05-14 |
TRACOE Medical GmbH | TRACOE Silcosoft Tracheostomy Tube | 2018-04-27 |
Lu Anne Bauer [TRACOE MEDICAL GMBH] | TRACOE cuff pressure monitor | 2017-01-13 |
TRACOE MEDICAL GMBH | TRACOE Cuff Pressure Monitor | 2016-12-21 |
Lu Anne Bauer [TRACOE MEDICAL GMBH] | TRACOE smart Cuff Manager | 2016-11-11 |
TRACOE MEDICAL GMBH | TRACOE Smart Cuff Manager | 2016-09-27 |
Lu Anne Bauer [TRACOE MEDICAL GMBH] | Neck straps | 2014-04-07 |
Lu Anne Bauer [TRACOE MEDICAL GMBH] | TRACOE mini Extension Piece | 2011-03-08 |
Lu Anne Bauer [TRACOE MEDICAL GMBH] | TRACOE tube clean Cleaning Swabs | 2011-01-19 |
Lu Anne Bauer [TRACOE MEDICAL GMBH] | TRACOE mini tracheostomy tube | 2008-04-16 |
Lu Anne Bauer [TRACOE MEDICAL GMBH] | TRACOE stoma and grid buttons | 2008-03-05 |
Lu Anne Bauer [TRACOE MEDICAL GMBH] | TRACOE comfort tubes and Accessory | 2007-12-06 |
Lu Anne Bauer [TRACOE MEDICAL GMBH] | TRACOE-VARIO TRACHEOSTOMY TUBES | 2007-12-06 |
Lu Anne Bauer [TRACOE MEDICAL GMBH] | TRACOE pure Tracheostomy Tubes | 2007-12-06 |
Lu Anne Bauer [TRACOE MEDICAL GMBH] | TRACOE PHON ASSIST 1 | 2007-12-06 |
Lu Anne Bauer [TRACOE MEDICAL GMBH] | TRACOE purofoam | 2007-07-23 |
Lu Anne Bauer [TRACOE MEDICAL GMBH] | PUROFOAM-AND GAUZE | 2007-07-23 |
TRACOE MEDICAL GMBH | TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470 | 2005-10-25 |
Lu Anne Bauer [TRACOE MEDICAL GMBH] | TRACOE twist & twist plus | 2005-03-24 |
TRACOE MEDICAL GMBH | TRACOE PHON ASSIST I - SPEAKING VALVES, REFERENCE MODELS: PHON ASSIST I-650-T/TO AND 650-S/SO | 2005-02-18 |
Lu Anne Bauer [TRACOE MEDICAL GMBH] | TRACOE TRACH CLEANING | 2004-07-07 |
Lu Anne Bauer [TRACOE MEDICAL GMBH] | TRACOE HUMID ASSIST | 2003-01-03 |
TRACOE MEDICAL GMBH | TRACHEOSTOMY TUBES TRACOE-FLEX | 1996-09-13 |
TRACOE MEDICAL GMBH | TRACHEOTOMY TUBES | 1978-10-24 |
| NCAGE Code | CB278 | TRACOE MEDICAL GMBH |
| CAGE Code | CB278 | TRACOE MEDICAL GMBH |