FDA Registration
Active
🇩🇪 Germany
TRACOE MEDICAL GMBH
Reg #: 8010485
·
FEI: 3003361161
·
Expires 2026
Products
12
Proprietary Names
18
Establishment Types
2
Classifications
12
Registration Details
- Registration Name
- TRACOE MEDICAL GMBH
- Registration Number
- 8010485
- FEI Number
- 3003361161
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- REICHELSHEIMER STR. 1/3
- City
- NIEDER-OLM Rhineland-Palatinate
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K152778
Owner / Operator
- Firm Name
- TRACOE MEDICAL GMBH
- Operator Number
- 8010485
- Address
- Reichelsheimer Str. 1/3, --
- City
- Nieder-Olm
- State
- Rhineland-Palatinate
- Postal Code
- 55268
- Country
- DE
- Correspondent
- Maximilian - Jurisch
US Agent
- Business Name
- COLOPLAST CORP.
- Contact Name
- Jason Woehrle
- Address
- 1601 West River Road N
- City
- Minneapolis
- State
- MN
- ZIP
- 55411
- Country
- US
- [email protected]
- Phone
- 612 7302063
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cuff, Tracheal Tube, Inflatable | BSK | Class 2 | Anesthesiology | No | 2017-01-13 |
| Tube Tracheostomy And Tube Cuff | JOH | Class 2 | Anesthesiology | No | 2021-08-10 |
| Connector, Airway (Extension) | BZA | Class 1 | Anesthesiology | No | 2011-03-08 |
| Tube, Laryngectomy | KAC | Class 1 | Ear, Nose, Throat | No | 2008-03-05 |
| Tracheostomy Cleaning Tray | OGV | Class 2 | Anesthesiology | No | 2020-09-10 |
| Condenser, Heat And Moisture (Artificial Nose) | BYD | Class 1 | Anesthesiology | No | 2003-01-03 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2007-07-23 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2011-01-19 |
| Tube, Tracheostomy (W/Wo Connector) | BTO | Class 2 | Anesthesiology | No | 2008-04-16 |
| Device, Fixation, Tracheal Tube | CBH | Class 1 | Anesthesiology | No | 2014-04-07 |
| Dilator, Tracheal | KCG | Class 1 | Ear, Nose, Throat | No | 2021-03-04 |
| Brush, Cleaning, Tracheal Tube | EPE | Class 1 | Anesthesiology | No | 2004-07-07 |
Proprietary Names
TRACOE cuff pressure monitor
TRACOE vario Tracheostomy Tube
TRACOE PHON ASSIST 1
TRACOE mini Extension Piece
TRACOE stoma and grid buttons
TRACOE smart Cuff Manager
TRACOE tube clean Cleaning Kit
TRACOE HUMID ASSIST
TRACOE purofoam
PUROFOAM-AND GAUZE
TRACOE twist & twist plus
TRACOE tube clean Cleaning Swabs
TRACOE mini tracheostomy tube
Neck straps
TRACOE experc Dilation Set
TRACOE silcosoft Tracheostomy Tube
TRACOE comfort tubes and Accessory
TRACOE TRACH CLEANING
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device