Neulasta
Catalogue number MT-101, listed by Sejoy Biomedical Co., Ltd., China, under Continuous Measurement Thermometer. 115 manufacturers in China are registered for this product code.
Continuous Measurement Thermometer
Who Makes This Device Type in China?
115 manufacturers in China hold an FDA registration for this device type, concentrated in Guangdong, Zhejiang and Jiangsu, and 10 other provinces. 17 of them are contract manufacturers, able to build to a buyer’s own specification.
- ADC Ningbo Co., Ltd. Zhejiang
- AID United International Co., Limited Shanghai
- Alicn Medical Shenzhen, Inc Guangdong
- Avita (Wujiang) Co., Ltd. Jiangsu, contract manufacturer
- Amphenol Medical Technologies (Dongguan) Co., Ltd. Guangdong, contract manufacturer
- Beijing Choice Electronic Technololgy Co., Ltd. Beijing
- Beijing Hongdee Corporation Beijing
- Betacera Inc. Jiangsu, contract manufacturer
- Bioland Technology Ltd. Guangdong
- Boluo Yuanzhou Dagao Electronics Co., Ltd. Xinjiang, contract manufacturer
- China (Shenyang) MED-Land IMP/EXP Corp., Ltd. Shanghai
- Conmo Electronic Company Limited Guangdong, contract manufacturer
- Contec Medical Systems Co., Ltd. Hebei
- Cotronic Technology Limited Guangdong, contract manufacturer
- Cardinal Medical Equipment Consulting (Shanghai)Co., Ltd. Shanghai
- Dongguan E-Test Technology Co., Ltd. Guangdong
- Dongguan Jiacom Technology Co., Ltd. Guangdong, contract manufacturer
- Dongguan Rongfeng Medical Co., Ltd. Guangdong
- Dongguan Simzo Electronic Technology Co., Ltd. Guangdong
- Drtv Asia Ltd Guangdong
- Dongguan CFE Electronic Co., Ltd. Guangdong, contract manufacturer
- Edan Instruments, Inc. Guangdong, contract manufacturer
- Elung Industrial Co., Ltd. Hong Kong
- EMI (Dongguan) Asia Limited Guangdong, contract manufacturer
- Essentia Industries Ltd. Guangdong, contract manufacturer
- Famidoc Technology Co., Ltd. Guangdong, contract manufacturer
- Firstar Healthcare Company Limited (Guangzhou) Guangdong, contract manufacturer
- Fudakang Industrial Co Ltd Guangdong
- GE Medical Systems (China) Co., Ltd. Jiangsu, contract manufacturer
- GFA Production Xiamen Co., Ltd. Fujian
- GRI Medical & Electronic Technology Co., Ltd. Zhejiang, contract manufacturer
- Guangdong Biolight Meditech Co., Ltd. Guangdong
- Guangdong Dexin Sports Industry Co., Ltd. Guangdong, contract manufacturer
- Guangdong Genial Technology Co., Ltd. Guangdong
- Guangzhou Baoli Hardware & Electronic Co., Ltd. Guangdong, contract manufacturer
- Guangdong Prestige Technology Co., Ltd. Guangdong
- Guangzhou Daxin Health Technology (Dongguan) Co., Ltd. Guangdong, contract manufacturer
- Hangzhou Hua'an Medical & Health Instruments Co., Zhejiang
- Hangzhou Universal Electronic Co., Ltd. Zhejiang
- Hangzhou VivaLNK Medical Technology Co., Ltd. Zhejiang
- Helen of Troy Macao Limited Guangdong
- Hetaida Technology Co., Ltd. Guangdong, contract manufacturer
- Hochuen Medical Technology Co., Ltd. Guangdong, contract manufacturer
- Inventech Xiamen Co., Ltd. Fujian, contract manufacturer
- Jiangmen ZHI QU Metal Plastic Industrial Co., Ltd. Guangdong
- Jiangsu NEW Pentastar Medical Products Co., Ltd. Jiangsu
- Jiangyin Sinbon Electronics Co Ltd Jiangsu, contract manufacturer
- Joytech Healthcare Co., Ltd. Zhejiang, contract manufacturer
- JWD. Technologies (Jiangmen) Co., Ltd. Guangdong
- Jiangsu Yuyue Medical Equipment & Supply Company Limited Jiangsu, contract manufacturer
- Kang ZE Industrial Co., Ltd. Guangdong
- Kangfu Medical Equipment Factory Zhejiang
- Kunshan Radiant Innovation Co., Ltd. Jiangsu, contract manufacturer
- Lakong Medical Devices Co., Ltd. Guangdong
- Medwell Technology Limited Guangdong, contract manufacturer
- NEW Prokin International Ltd. Guangdong, contract manufacturer
- Ningbo Just Soon Industrial Limited Zhejiang
- Ningbo Ranor Medical Science & Technology Co., Ltd. Zhejiang, contract manufacturer
- Onbo Electronic (Shenzhen) Co., Ltd. Guangdong, contract manufacturer
- Orantech Inc. Guangdong, contract manufacturer
- Pinghu Sama Medical Packing Co., Ltd. Zhejiang, contract manufacturer
- Planet(Shanghai) International Co., Ltd. Shanghai
- Philips Goldway (Shenzhen) Industrial Inc. Guangdong
- Qingdao Yasee Medical Device Co., Ltd. Shandong, contract manufacturer
- Shandong Zhushi Pharmaceutical Group Co., Ltd. Shandong, contract manufacturer
- Shenzhen Aeon Technology Co., Ltd. Guangdong
- Shenzhen Brav Electronic Technologies Co., Ltd. Guangdong, contract manufacturer
- Shenzhen BSX Technology Electronics Co., Ltd. Guangdong
- Shenzhen Changke Connect Electronics Co., Ltd. Guangdong
- Shenzhen Changkun Technology Co., Ltd. Guangdong, contract manufacturer
- Shenzhen Comen Medical Instruments Co., Ltd. Guangdong, contract manufacturer
- Shenzhen Creative Industry Co., Ltd. Guangdong
- Shenzhen Everbest Machinery Industry Co Ltd Guangdong
- Shenzhen Finicare Co., Ltd. Guangdong
- Shenzhen Hetaida Technology Limited Company Guangdong
- Shenzhen Juzhong Technology Co., Ltd. Guangdong
- Shenzhen Launch Electrical Co., Ltd. Guangdong, contract manufacturer
- Shenzhen MED-Link Electronics Tech Co., Ltd. Guangdong, contract manufacturer
- Shenzhen Medke Technology Co., Ltd. Guangdong
- Shenzhen Mindray BIO-Medical Electronics Co., Ltd. Guangdong
- Shenzhen Mondial Technology Co., Ltd. Guangdong, contract manufacturer
- Shenzhen Sino-K Medical Technology Co., Ltd. Guangdong
- Shenzhen Urion Technology Co., Ltd. Guangdong
- Shenzhen Zhengkang Technology Co., Ltd. Guangdong
- Suzhou Melodicare Medical Technology Co., Ltd. Jiangsu
- Suzhou Pipi Medical Products Co., Ltd. Jiangsu, contract manufacturer
- Shenzhen AOJ Medical Technology Co., Ltd. Guangdong, contract manufacturer
- Shenzhen BelterHealthMeasurementAndAnalysisTechnologyCo.,Ltd Guangdong
- Shenzhen Calibeur Industries Co., Ltd. Guangdong
- Shenzhen Caremed Medical Technology Co., Ltd. Guangdong, contract manufacturer
- Shenzhen Jumper Medical Equipment Co., Ltd. Guangdong
- Shenzhen Pango Medical Electronics Co., Ltd. Guangdong
- Shenzhen Rongfeng Technology Co., Ltd. Guangdong
- Smart Technology Co., Ltd. Guangdong
- Starboard Medical (Jiangsu) Co., Ltd. Jiangsu, contract manufacturer
- Sterigenics Shanghai ETO Ltd. Shanghai, contract manufacturer
- Suzhou Meccan Import and Export Corp. Jiangsu, contract manufacturer
- Taizhou City K&W International Trade Co., Ltd. Jiangsu
- Tasco Medical Industries Co., Ltd. Guangdong, contract manufacturer
- Tianjin Choice Medical Device Co., Ltd. Tianjin, contract manufacturer
- Unimed Medical Supplies Inc Guangdong, contract manufacturer
- Vega Technologies Inc. Guangdong
- Well Lead Medical Co., Ltd. Guangdong, contract manufacturer
- Wenzhou Caretek Medical Device Co., Ltd. Zhejiang, contract manufacturer
- Wenzhou Yosun Medical Technology Co., Ltd. Zhejiang, contract manufacturer
- Wuhan Strong Electronics Hubei, contract manufacturer
- Xiamen Ants BRO Technology Co., Ltd. Fujian
- Xiamen Firstcare IMP. & EXP. Co., Ltd. Fujian
- Xuzhou Yongkang Electronic Science Technology Co., Ltd. Jiangsu, contract manufacturer
- Yiwu Thousand Shores E-Business Co., Ltd. Zhejiang
- Yiwu Ori-Power Medtech Co., Ltd. Zhejiang, contract manufacturer
- Zhejiang Hongyu Medical Commodity Co., Ltd. Zhejiang, contract manufacturer
- Zhongshan Jinli Electronic Weighing Equipment Co., Ltd. Guangdong
- Zhuhai Yueja Medical Device Technology Co., Ltd. Guangdong
- Zhuzhou Goldenhot Medical Technology Co., Ltd. Hunan
What Is It?
A continuous measurement thermometer is a clinical electronic thermometer indicated to measure the body or skin temperature of a person continuously or in specified intervals. Under this regulation, this product code represents non-exempt devices. For more information, see 90 FR 25889, available at https://www.govinfo.gov/content/pkg/FR-2025-06-18/pdf/2025-11207.pdf.
How Is FLL Classified?
Continuous Measurement Thermometer is FDA product code FLL, Class 2, 21 CFR 880.2910.
How Does It Reach the US Market?
A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. The review can be done by an FDA-accredited third party, which is usually faster. Chinese applicants hold 186 clearances under this code; the FDA took a median of 180 days from receipt to decision on them.
7 went the Special 510(k) route, the one for a change to the applicant’s own cleared device. 15 were reviewed by an accredited third party.
What Has Gone Wrong With It?
The FDA has recorded 18 recalls under this product code since 2003. None was by a company in China. The root causes the FDA records most often are Process control (3), Use error (2) and Labeling design (2).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.
Name
Record
Equinox
Catalogue number EQ-THERM03, listed by Guangzhou Berrcom Medical Device Co., Ltd., China, under Continuous Measurement Thermometer. 115 manufacturers in China are registered for this product code.
Comen
Catalogue number C30, listed by Shenzhen Comen Medical Instruments Co., Ltd., China, under Continuous Measurement Thermometer. 115 manufacturers in China are registered for this product code.
Handy Solutions
Catalogue number 28117, listed by Navajo Manufacturing Company, United States, under Continuous Measurement Thermometer. 115 manufacturers in China are registered for this product code.