Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030089838

FEI Number

3030089838

Entity Name

TE Sensores S. de R.L. de C.V

City/State/Country

Hermosillo Mexico, MX

Establishment Address

Av. Obrero Mundial No. 9, Parque Industrial Dynatech, Colonia el Sahuaro, Hermosillo Mexico 83170, MX

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

TE Connectivity (Owner Number: 10089420)

Owner / Operator Contact Address

1740 Joe Battle Blvd, Bldg. 3, El Paso, TX 79936, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K921561

PMA Number

N/A

All Registered Proprietary Names

Stryker 8001-063-412 Series Esophageal/Rectal Temp Probe, 21651-4492 MEAS 4400 Series 9FR ESOPH/REC Temp Probe, 4491 Stryker 8001-063-409 Series Esophageal/Rectal Temp Probe, 21651-4491 Draeger, 20930, Probe5, IG Skin temp, MU12551, Probe, Dual 21369-16,AIRWAY PROBE,11816-88 21369-17,AIRWAY PROBE,11817-88 21666,MEDTR-1384,M957057A001 21665,MEDTR-ATP210 M939195A002 21664,MEDTR- TP, M957061A001 19274 T/W PROBE, COBE LAB International Biomedical 405 Probe, SP21690 20289 T/W PROBE,SORIN BIO Stryker 8001-063-414 Series Foley Catheter Temperature Probe, 21651-4464

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2024-11-21
FMZ	Incubator, Neonatal	General Hospital	Class 2	880.5400	2024-11-22
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2025-06-02
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2024-06-28
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2024-06-28
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2024-11-21

Official Correspondent

Delton Carter

US Agent Details

Delton Carter Business: TE CONNECTIVITY Email: TE-MEAS_Regulatory@te.com Phone: (980) 2696234

Related Public Records

Same Entity

TE Connectivity

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3011369688	Measurement Specialties Chengdu	Chengdu Sichuan, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K010462	Avita Corporation	AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)	2001-04-11
K760421	Arbrook Mfg. Corp.	THERMOMETER, SURVALENT-ELECTRONIC	1976-08-23
K813409	Yellow Springs Instrument Co., Inc.	MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER	1981-12-18
K830039	Science Development Corp.	SDC RECTAL TEMP. PROBE PRODUCT #1020	1983-02-23
K842199	Sharp Electronics Corp.	ELEC. DIGITAL THERMOMETER MT-20 & 30	1984-07-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-2020	Ohmeda Medical	2	Giraffe Omnibed - Product Usage: The OmniBed is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user s demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Incubators provide an enclosed, temperature-controlled environment and warmers provide infrared heat in an open environment. They may also be used for short periods of time to facilitate the neonate s transition from the uterus to the external environment. This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide stable oxygen concentration within the infant compartment at the value set by the operator (21-65%).

Similar Registrations

Registration Number	Establishment Name	Location
1062836	DIGICARE BIOMEDICAL TECHNOLOGY, INC.	BOYNTON BEACH, FL, US
3009487317	SHENZHEN JUZHONG TECHNOLOGY CO.,LTD	shenzhen Guangdong, CN
9681837	ME CENTER OF TERUMO CORP.	FUJINOMIYA Shizuoka, JP
3038761440	Corsano Health SA	Plan-les-Ouates Geneve, CH
3016595211	DYNAMIC EMS LTD	Dalgety Bay Fife, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030089838. Last updated year: 2026. Please use registration number 3030089838 when referencing this establishment in official correspondence.