Na Tecotherm Neo

by TEC COM GmbH, Gesellschaft für Technik, Technologie und Vermarktung

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number04260498580002 UDI-DI	Date1 Dec 2016Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic Name: External circulating-fluid core temperature regulation system control unit, heating/cooling
Model / Reference: TECOTHERM NEO

Primary DI / UDI-DI: 04260498580002
FDA Product Code: DWJ
GMDN Term: External circulating-fluid core temperature regulation system control unit, heating/cooling

Device Class: Class II
Regulation Number: 870.5900
GUDID distribution status: In Commercial Distribution

Properties

Prescription Use
Serial Number
Manufacturing Date

Other properties (11)

Sterile: No
Single Use: No
Implantable: No
Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Lot / Batch Number: No
Expiration Date: No