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Beijing Fukuda Denshi Medical Instruments Co., Ltd.

✓ Record-verifiedregistrations found in 9 marketsEU SRN JP-MF-000008253Unified social credit code 91110302600025412G

This company holds 9 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Canada, Taiwan, Singapore, South Korea, Australia — 8 overseas markets. EU UDI-DI records ≥300, the first 300 verified individually.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

9China registrations

Class II 9

as of 2026-09-04

EUEuropean UnionEUDAMED

≥300UDI-DI device records

Class I 273Class IIa 6Class IIb 21

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

18listed device types

Class I 2Class II 14Class III 0unclassified 2

plus 69 registration records and 70 510(k)

UKUnited KingdomMHRA PARD

48registered device records

Class I 36Class IIa 7Class IIb 5

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

15active device licences

Class II 10Class III 5

22 including historic records

TWTaiwanTFDA

5valid device licences

Class II 5

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

1active ARTG entries

IIa 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

European Union441 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified

United States69 registration records, 70 510(k), 0 PMA

China9 certificates (Class III 0 / II 9 / I 0), as of 2026-09-04

United Kingdom48 confirmed, 0 excluded

Canada15 confirmed, 0 excluded

Manufacturer names merged into this page: FUKUDA DENSHI CO., LTD. · FUKUDA DENSHI USA, INC. · Fukuda Denshi Fine Tech Sendai Co. Ltd. · FUKUDA DENSHI CO. LTD · FUKUDA DENSHI USA INC.

Regulatory identity

EU manufacturer SRN: JP-MF-000008253
EU authorised representative: Emergo Europe B.V.
UK responsible person: FUKUDA DENSHI UK LTD
Unified social credit code: 91110302600025412G
Exhibition record: CMEF 89th (Apr 2024, Shanghai)

Business registration

Registration status: Active
Incorporated: 1994-05-09
Registered capital: CNY 47,306,090
Paid-in capital: CNY 3,900,000
Legal form: Limited liability company (wholly owned by a foreign corporation)
Industry classification: Special-purpose equipment manufacturing
Last approval date: 2026-03-17
Recognitions: Micro and small enterpriseGazelle enterprise

Business registration data from Tianyancha, as of 2026-09-03. Public registry information only; legal representative and contact-person details are not collected. The figure is the number of employees enrolled in social insurance as declared by the company, which may differ from actual headcount.

FDA 510(k) clearances by year

31991

11992

21993

11994

31995

11996

61997

41998

11999

12000

12001

12002

22003

22004

12005

32008

12009

32011

22015

12018

FDA listed device types

showing 8 of 18

Dislodger, Stone, Basket, Ureteral, Metal 1Detector And Alarm, Arrhythmia 1Transducer, Ultrasonic, Diagnostic 1System, Measurement, Blood-Pressure, Non-Invasive 1System, Imaging, Pulsed Echo, Ultrasonic 1System, Imaging, Pulsed Doppler, Ultrasonic 1Monitor, Breathing Frequency 1Electrocardiograph 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	京械注准20252070165	动脉硬化检测仪	Class II
CN	京械注准20192070618	多道心电图机	Class II
CN	京械注准20192070404	六道自动分析心电图机	Class II
CN	京械注准20192070388	十二道自动分析心电图机	Class II
EU	04538612915741	Toe Blood Pressure Package	Class I
EU	04538612915734	Four Limbs NIBP Package	Class I
EU	04538612151569	SD Card	Class I
EU	04538612228070	SD Card	Class I
UK	34978	All Purpose Blood Pressure Cuff	Class I
UK	37336	PCG Microphone	Class I
UK	38470	DYNASCOPE 1000 Series DS-1700 System	Class IIb
US	K173226	CardiMax Electrocardiograph	2018-04-16
US	K150030	Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor	2015-03-16
US	K134046	FUKUDA DENSHI DYNASCOPE MODEL DS-8100N/8100M PATIENT MONITOR	2015-02-12
CA	2627	FF SONIC UF-4500 GENERAL PURPOSE ULTRASOUND SCANNER	Class II
CA	8764	PHV-1000 HEART VIEW PORTABLE ECG MONITOR	Class II
CA	13006	FCP-4101 ELECTROCARDIOGRAPH	Class II

Beijing Fukuda Denshi Medical Instruments Co., Ltd.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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