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Tracoe medical GmbH

Last updated May 24, 2026

What Tracoe medical GmbH makes

The company produces tracheostomy tubes in various forms, including non-reinforced and reinforced designs for single-use and reusable applications. Their portfolio also includes tracheostomy tube dressings, reusable neck holders, lubricants, and single-use tracheostomy kits. Device examples include TRACOE silcosoft, TRACOE vario, TRACOE comfort, and TRACOE twist series products.

These devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identification (UDI) system. The manufacturer operates from the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Tracoe medical GmbH manufacture?

Tracoe medical GmbH specializes in tracheostomy-related products. Their portfolio includes tracheostomy tubes (both single-use and reusable, with reinforced and non-reinforced options), tracheostomy tube dressings, reusable neck holders, lubricants, and single-use tracheostomy kits. Examples of their products are the TRACOE silcosoft, TRACOE vario, TRACOE comfort, and TRACOE twist series.

Where is Tracoe medical GmbH based?

Tracoe medical GmbH is based in the United States. The company’s location is relevant for regulatory oversight and compliance, as it operates under the jurisdiction of the FDA.

Which regulatory registries list Tracoe medical GmbH’s devices?

Tracoe medical GmbH’s devices are listed in the FDA’s Unique Device Identification (UDI) system. This registry helps track and identify medical devices for regulatory, safety, and compliance purposes, ensuring transparency in the supply chain.

How are Tracoe medical GmbH’s devices classified under FDA regulations?

Tracoe medical GmbH’s devices fall under FDA’s Class I and Class II categories. Class I devices generally pose minimal risk and are subject to general controls, while Class II devices require additional performance standards due to moderate risk. The classification depends on factors like the device’s purpose, design, and potential patient risk.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: —
Website: tracoe.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +49613691690
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 319414785

Catalogue (2068)

Page 2 of 42

Device	Model / Reference	Registries	Class	Status
TRACOE® comfort	REF 104-08N-O	FDA UDI	Class II	Unknown
TRACOE® comfort	REF 205-14IK-1	FDA UDI	Class II	Unknown
TRACOE® comfort	REF 888-106-09D	FDA UDI	Class II	Unknown
TRACOE® comfort	REF 202-13D	FDA UDI	Class II	Unknown
TRACOE® twist	REF 302-07-P	FDA UDI	Class II	Unknown
TRACOE® comfort	REF 201-10	FDA UDI	Class II	Unknown
TRACOE® comfort	REF 888-103-03A-N	FDA UDI	Class II	Unknown
TRACOE silcosoft	REF 360-2.5	FDA UDI	Class II	Active
TRACOE comfort	REF 888-103-05	FDA UDI	Class II	Active
TRACOE comfort	REF 108-11	FDA UDI	Class II	Active
TRACOE® comfort	REF 888-104-06N-O	FDA UDI	Class II	Unknown
TRACOE comfort	REF 888-105-12-2D	FDA UDI	Class II	Active
TRACOE® comfort	REF 888-204-07A-N	FDA UDI	Class II	Unknown
TRACOE silcosoft	REF 371-4.0-C65	FDA UDI	Class II	Active
TRACOE® comfort	REF 888-103-05N-O	FDA UDI	Class II	Unknown
TRACOE silcosoft	REF 371-5.5-C55	FDA UDI	Class II	Active
TRACOE comfort	REF 103-12N	FDA UDI	Class II	Active
TRACOE® comfort	REF 102-08IK-1	FDA UDI	Class II	Unknown
TRACOE comfort	REF 202-07	FDA UDI	Class II	Active
TRACOE comfort	REF 104-11	FDA UDI	Class II	Active
TRACOE comfort	REF 888-105-09-1D	FDA UDI	Class II	Active
TRACOE comfort	REF 205-11-1	FDA UDI	Class II	Active
TRACOE® comfort	REF 888-101-13	FDA UDI	Class II	Unknown
TRACOE comfort	REF 107-11	FDA UDI	Class II	Active
TRACOE® comfort	REF 102-09D-F	FDA UDI	Class II	Unknown
TRACOE silcosoft	REF 371-5.0-C63	FDA UDI	Class II	Active
TRACOE silcosoft	REF 370-3.5-C65	FDA UDI	Class II	Active
TRACOE comfort	REF 202-11	FDA UDI	Class II	Active
TRACOE comfort	REF 888-103-05A-N	FDA UDI	Class II	Active
TRACOE twist plus	REF 523-09-X	FDA UDI	Class II	Active
TRACOE® comfort	REF 104-11N-O	FDA UDI	Class II	Unknown
TRACOE® comfort	REF 888-202-13IK-1	FDA UDI	Class II	Unknown
TRACOE® comfort	REF 888-103-13	FDA UDI	Class II	Unknown
TRACOE silcosoft	REF 372-3.0-C34	FDA UDI	Class II	Active
TRACOE comfort	REF 888-101-06	FDA UDI	Class II	Active
TRACOE® comfort	REF 888-106-08D	FDA UDI	Class II	Unknown
TRACOE comfort	REF 104-06A-O	FDA UDI	Class II	Active
TRACOE silcosoft	REF 372-4.5-C60	FDA UDI	Class II	Active
TRACOE comfort	REF 204-05A-O	FDA UDI	Class II	Active
TRACOE silcosoft	REF 372-3.0	FDA UDI	Class II	Active
TRACOE silcosoft	REF 371-3.5-C50	FDA UDI	Class II	Active
TRACOE silcosoft	REF 370-3.5-C34	FDA UDI	Class II	Active
TRACOE® comfort	REF 888-102-12IK-1	FDA UDI	Class II	Unknown
TRACOE® comfort	REF 888-104-11IK	FDA UDI	Class II	Unknown
TRACOE silcosoft	REF 370-2.5-C44	FDA UDI	Class II	Active
TRACOE® comfort	REF 888-115-08IK-2	FDA UDI	Class II	Unknown
TRACOE® comfort	REF 888-214-05	FDA UDI	Class II	Unknown
TRACOE® comfort	REF 102-11IK-1	FDA UDI	Class II	Unknown
TRACOE silcosoft	REF 372-4.0-C38	FDA UDI	Class II	Active
TRACOE comfort	REF 888-215-10-2	FDA UDI	Class II	Active

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Tracoe Medical Gmbh NIEDER-OLM Rhineland-Palatinate · DE FEI 3003361161