Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8010485

FEI Number

3003361161

Entity Name

TRACOE MEDICAL GMBH

City/State/Country

NIEDER-OLM Rhineland-Palatinate, DE

Establishment Address

REICHELSHEIMER STR. 1/3, NIEDER-OLM Rhineland-Palatinate D-55268, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

TRACOE MEDICAL GMBH (Owner Number: 8010485)

Owner / Operator Contact Address

Reichelsheimer Str. 1/3, --, Nieder-Olm, DE-RP 55268, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K172720

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BSK	Cuff, Tracheal Tube, Inflatable	Anesthesiology	Class 2	868.5750	2017-01-13
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2021-08-10
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2007-12-06
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2011-03-08
KAC	Tube, Laryngectomy	Ear, Nose, Throat	Class 1	874.4420	2008-03-05
BSK	Cuff, Tracheal Tube, Inflatable	Anesthesiology	Class 2	868.5750	2016-11-11
OGV	Tracheostomy Cleaning Tray	Anesthesiology	Class 2	868.5800	2020-09-10
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	2003-01-03
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2007-07-23
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2005-03-24
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2011-01-19
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	Class 2	868.5800	2008-04-16
CBH	Device, Fixation, Tracheal Tube	Anesthesiology	Class 1	868.5770	2014-04-07
KCG	Dilator, Tracheal	Ear, Nose, Throat	Class 1	874.4420	2021-03-04
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2018-05-14

Official Correspondent

Maximilian Jurisch

US Agent Details

Jason Woehrle Business: COLOPLAST CORP. Email: usjawo@coloplast.com Phone: (612) 7302063

Related Public Records

Same Entity

TRACOE MEDICAL 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
K142298	Covidien	Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard Cuff	2015-02-13
K182861	Covidien	Shiley Neonatal/Pediatric Tracheostomy Tube	2019-03-22
K142296	Covidien	Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner Cannula	2015-02-24
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-2014	H & H Associates	2	H&H Emergency Cricothyrotomy Kit (Part No. HHECT01/ HHECTK01, NSN 6515-01-573-0692), vacuum sealed and packaged in a 5 mil poly bags, labeled in part *H & H Associates, Inc. CAGE 1NNH6 www.gohandh.com Ordinary, VA 23131 (800) 326-5708*. The product is used to maintain fracture alignment.
Z-0044-2017	Teleflex Medical	2	Willy Rusch GmbH Tracheostomy Tube Set Cannulation of tracheotomised patients, particularly in the case of a narrow tracheostoma and narrow-lumen tracheas. When using cannulas with curr. For short term intermittent inflation.
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019	COVIDIEN LLC	1	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010485. Last updated year: 2026. Please use registration number 8010485 when referencing this establishment in official correspondence.