Telemetry Accessories

ECG 5 lead Grabber, AAMI + SpO2, SPU, Tele

Registry build 21.09.26
10manufacturers in China registered for this device type
5catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (6), Jiangsu (1), Hebei (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code DSI
Manufacturer City Province Registered as Device types
Amphenol Medical Technologies (Dongguan) Co., Ltd. Dongguan Guangdong Contract manufacturer 77
Linxens Healthcare (Tianjin) Co., Ltd. Jinnan District Tianjin Contract manufacturer 7
Shenzhen Mindray BIO-Medical Electronics Co., Ltd. Shenzhen Guangdong Specification developer 61
GE Medical Systems (China) Co., Ltd. Wuxi Jiangsu Contract manufacturer 57
Edan Instruments, Inc. Shenzhen Guangdong Contract manufacturer 56
Orantech Inc. Shenzhen Guangdong Contract manufacturer 40
Shenzhen Comen Medical Instruments Co., Ltd. Shenzhen Guangdong Contract manufacturer 24
Contec Medical Systems Co., Ltd. Qinhuangdao Hebei Manufacturer 22
Guangdong Biolight Meditech Co., Ltd. Zhuhai Guangdong Manufacturer 19
Shandong Corecare Technology Limited Jinan Shandong Manufacturer 2

Record

Regulatory record for Telemetry Accessories
Listed by Philips Medizin Systeme Böblingen GmbH, Germany
FDA product code DSI
Device type Detector And Alarm, Arrhythmia
Device class Class 2
Regulation 21 CFR 870.1025
Record published 2026-05-19
Record revised 2026-07-23 (version 2)

Specifications

Specifications
MRI safety MR Unsafe
Single use Yes
Prescription Prescription only
Label carries lot or batch number
Storage Storage environment temperature 12 to 35 °C; Storage environment temperature 53.6 to 95 °F; Storage environment atmospheric pressure 10 to 108 KiloPascal; Storage environment humidity 18 to 78 % RH
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Telemetry Accessories
Catalogue number Size Per pack Status
ECG 5 Lead Grabber IEC + SpO2, SPU, Tele 20 In distribution
ECG 5 lead Grabber, AAMI + SpO2,SPU,Tele 20 In distribution
ECG Trunk Cable AAMI/IEC In distribution
ECG 5 lead Grabber, IEC, SPU, Tele 20 In distribution
ECG 5 lead Grabber, AAMI, SPU, Tele 20 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Trulink Spacelabs Healthcare (Washington), Inc 160
Fukuda Denshi Fukuda Denshi Co., Ltd. 30
Q-Tel RMS Mortara Instrument, Inc. 20
Detector And Alarm, Arrhythmia Philips Medical Systems Hsg 20
ECG Electrodes Philips Medical Systems Hsg 19
Seeq™ Medtronic, Inc. 18
Life Sensing Instruments, Inc. Life Sensing Instruments, Inc. 17
NIBP Cuffs Philips Medical Systems Hsg 14
Waveline EZ+ Avante 11
BodyGuardian Preventice Technologies, Inc. 10
BodyGuardian Kit Preventice Technologies, Inc. 8
Waveline Pro+ Avante 7

Showing 12 of 112. All products under Detector And Alarm, Arrhythmia

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer