TEC COM MEDIZINTECHNIK GMBH

FDA Device Registration & Listing · Kabelsketal Saxony-Anhalt, DE · Registration 3016507522

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3016507522
FEI Number
3016507522
Entity Name
TEC COM MEDIZINTECHNIK GMBH
City/State/Country
Kabelsketal Saxony-Anhalt, DE
Establishment Address
Am Kruemmling 1, Kabelsketal Saxony-Anhalt 06184, DE
Establishment Type(s)
Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Tec Com Medizintechnik GmbH (Owner Number: 10061013)
Owner / Operator Contact Address
Am Kruemmling 1, Kabelsketal, DE-ST 06184, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

TECOtherm NEO

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DWJ System, Thermal Regulating Cardiovascular Class 2 870.5900 2023-11-20
FOH Mattress, Water, Temperature Regulated General Hospital Class 1 880.5560 2019-12-06

Official Correspondent

Sebastian Dr. Ebert

US Agent Details

Amy Piper Business: International Biomedical Email: regulatory@int-bio.com Phone: (512) 8730033

Related Public Records

Same Entity

Tec Com Medizintechnik 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
K171373 3M Company 3M Bair Hugger Model 675 Total Temperature Management System 2017-10-10
K083336 Smiths Medical Asd, Inc. LEVEL 1 SNUGGLE WARM ADULT UNDERBODY CONVECTIVE WARMING BLANKET, MODEL SW-2013, LEVEL 1 SNUGGLE WARM LEFT LATERAL 2009-06-03

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0035-2010 Cincinnati Sub-Zero Products Inc 2
WarmAir 135 Thermal Regulating System. Catalog Numbers: 86186-115 V, 06186-115 V (sold in the U.S.) and #86185-100 V ( not sold in the U.S.). Intended for warming patients before, during and after surgery, and other specialty procedures.

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3012307300 ICU Medical, Inc. Minneapolis, MN, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016507522. Last updated year: 2026. Please use registration number 3016507522 when referencing this establishment in official correspondence.
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