Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010476117

FEI Number

3010476117

Entity Name

BETACERA INC.

City/State/Country

Suzhou City Jiangsu, CN

Establishment Address

No. 1219 YunLi Road, WuJiang Development Zone, Suzhou City Jiangsu 215200, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Betacera Inc. (Owner Number: 10048284)

Owner / Operator Contact Address

No. 1219 YunLi Road, WuJiang Development Zone, Suzhou City, CN-JS 215200, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Teleflex; DISPOSABLE TEMPERATURE PROBE-72 Teleflex; DISPOSABLE TEMPERATURE PROBE-60 21543-3,ADULT GP PROBE MP00992 21545-3, ADULT SKIN PROBE MP00996 21546,PEDIATRIC SKIN PROBE MP00997 21544, PEDIATRIC GP PROBE MP00993 21546-3,PEDIATRIC SKIN PROBE MP00998 20930,MU12551,PROBE,DUAL Skin Probe, Draeger MU26036 21544-3,PEDIATRIC GP PROBE MP00994 "21547,MX-11000 PROBE,5/BAG (Disposable Skin Probe-Infant)" 20929,MU11228,DUAL,DISPOSABLE 21570, Neonatal Skin Probe MX-11001 SP21545, ADULT SKIN PROBE MP00995 Skin Probe, Draeger MU26035 21543, ADULT GP PROBE MP00991

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2020-01-08
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2016-11-08

Official Correspondent

Brown Koo

US Agent Details

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

Related Public Records

Same Entity

Betacera Inc.

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
K012633	Respironics, Inc.	RESPIRONICS HEATED HUMIDIFIER	2002-02-28
K970478	Marquest Medical Products, Inc.	SCT 3000 HEATED HUMIDIFIER	1997-07-16
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

Similar Registrations

Registration Number	Establishment Name	Location
3010063021	TNI MEDICAL AG	Wurzburg Bavaria, DE
2085602	FISHER & PAYKEL HEALTHCARE, INC.	IRVINE, CA, US
3029906224	Hamilton Medical AG	Domat/Ems Graubunden, CH
3011137372	Teleflex Medical LLC	Morrisville, NC, US
9611451	FISHER & PAYKEL HEALTHCARE, LTD.	EAST TAMAKI Auckland, NZ

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010476117. Last updated year: 2026. Please use registration number 3010476117 when referencing this establishment in official correspondence.