PageWriter

PageWriter TC70 US Government all-inclusive bundle with trolley Includes A02 Cardiograph+D01 All Orders+D02 ADT Support+D03 DXL ECG Interpretation+D05 ECG Full disclosure+D06 ECG…

Registry build 21.09.26

PageWriter TC70 US Government all-inclusive bundle with trolley Includes A02 Cardiograph+D01 All Orders+D02 ADT Support+D03 DXL ECG Interpretation+D05 ECG Full disclosure+D06 ECG Archive+D08 DICOM ECG result output+D12 Last ECG InterAct Query+D24 Wireless 802 11 abgn SWHW+D50 WIN CE7+E06 Double Sided Tab Clips+H15 Second Battery+H16 Membrane Keyboard+H21 PIM 12 Lead+H23 Long Lead Wires+W01 Onsite Repair+M2481A+13943B 10packs+860318 B01 Partially Assembled Trolley+C02 Storage Bin+C04 Wire Basket

18manufacturers in China registered for this device type
10catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (10), Jiangsu (2), Beijing (1). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code DPS
Manufacturer City Province Registered as Device types
Amphenol Medical Technologies (Dongguan) Co., Ltd. Dongguan Guangdong Contract manufacturer 77
Amphenol Alden Products Company Shenzhen Guangdong Contract manufacturer 24
Tianjin Choice Medical Device Co., Ltd. Tianjin Tianjin Contract manufacturer 12
Yahorng Dongguan Electronic Co Ltd Guangdong Guangdong Contract manufacturer 8
Omron (Dalian) Co., Ltd. (Plant 1) Dalian Liaoning Contract manufacturer 7
Wuhan Strong Electronics Wuhan Hubei Contract manufacturer 6
Regent Electron Suzhou Co., Ltd. Wujiang Jiangsu Contract manufacturer 5
Ryder Electronics (Shenzhen) Ltd. Shenzhen Guangdong Contract manufacturer 5
GE Medical Systems (China) Co., Ltd. Wuxi Jiangsu Contract manufacturer 57
Edan Instruments, Inc. Shenzhen Guangdong Contract manufacturer 56
Beijing Choice Electronic Technololgy Co., Ltd. Beijing Beijing Repacker / relabeller 30
Shenzhen Comen Medical Instruments Co., Ltd. Shenzhen Guangdong Contract manufacturer 24

Showing 12 of 18. All 18 manufacturers in China registered for Electrocardiograph

Record

Regulatory record for PageWriter
Listed by Philips Medical Systems Hsg
FDA product code DPS
Device type Electrocardiograph
Device class Class 2
Regulation 21 CFR 870.2340
Record published 2016-09-15
Record revised 2026-02-26 (version 13)

Specifications

Specifications
MRI safety MR Unsafe
Prescription Prescription only
Label carries serial number
Storage Storage environment temperature -20 to 50 °C; Storage environment atmospheric pressure 572 to 1014 millibar; Storage environment humidity 10 to 90 % RH
Distribution end date 2026-03-06

Catalogue Numbers

Catalogue numbers for PageWriter
Catalogue number Size Status
PageWriter TC35 Cardiograph In distribution
PageWriter TC50 Cardiograph Withdrawn
PageWriter TC30 Cardiograph Withdrawn
TC30 government bundle without trolley Withdrawn
TC70 government bundle without trolley Withdrawn
TC70 government Bundle w trolley Withdrawn
TC30 government Bundle w trolley Withdrawn
TC50 Government Bundle With Trolley Withdrawn
TC50 Withdrawn
PageWriter TC70 Cardiograph Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Welch Allyn, Inc. Welch Allyn, Inc. 1,734
M Series Biphasic Zoll Medical Corporation 93
ELI 380 Mortara Instrument, Inc. 69
Patient Cable Lead Set Mortara Instrument, Inc. 56
ELI 250c Mortara Instrument, Inc. 50
Lutech Lutech Industries 49
ELI 150c Mortara Instrument, Inc. 47
Fukuda Denshi Fukuda Denshi Co., Ltd. 41
ELI 280 Mortara Instrument, Inc. 41
Electrocardiograph Edan Instruments, Inc. 38
Q-Stress Mortara Instrument, Inc. 25
XScribe Mortara Instrument, Inc. 22

Showing 12 of 177. All products under Electrocardiograph

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