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Edan Instruments, Inc.

China · Shenzhen · www.edan.com

✓ Record-verifiedregistrations found in 13 marketsEU SRN CN-MF-000009957Unified social credit code 914403001923672010

This company holds 147 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 12 overseas markets. EU UDI-DI records ≥40, the first 300 verified individually.

Registrations by market

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

CNChinaNMPA

147China registrations

Class I 41Class II 90Class III 16

as of 2026-09-04

EUEuropean UnionEUDAMED

≥40UDI-DI device records

Class I 25Class IIa 5Class IIb 8IVD A 2

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

USUnited StatesFDA openFDA

56listed device types

Class I 4Class II 51Class III 0unclassified 1

plus 67 registration records and 94 510(k)

UKUnited KingdomMHRA PARD

47registered device records

Class I 7Class IIa 16Class IIb 7IVD A 6IVD B 4IVD C 3IVD general 4

BRBrazilANVISA

62registered devices

Class I 22Class II 40

82 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

14active device licences

Class II 4Class III 10

52 including historic records

TWTaiwanTFDA

21valid device licences

Class II 21

SGSingaporeHSA SMDR

10device registrations

CLASS B 4CLASS C 6

KRSouth KoreaMFDS GMP

4GMP quality-system certificates

Import 3IVD import 1

AUAustraliaTGA ARTG

47active ARTG entries

Class I 14IIa 13IIb 20

HKHong KongMDACS

50valid listings

Class II 29Class III 19IVD C 2

ILIsraelAMAR

35registrations

RURussiaRoszdravnadzor

24active registrations

Class 2a 14Class 2b 10

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 Union1,933 raw hits, 260 excluded, 40 confirmed. Large result set — only the first 300 verified

United States67 registration records, 94 510(k), 0 PMA, 1 excluded

China147 certificates (Class III 16 / II 90 / I 41), as of 2026-09-04

United Kingdom47 confirmed, 3 excluded

Brazil62 confirmed, 0 excluded

Canada14 confirmed, 0 excluded

Manufacturer names merged into this page: EDAN INSTRUMENTS, INC. · EDAN INSTRUMENTS, INC

Regulatory identity

EU manufacturer SRN: CN-MF-000009957
EU authorised representative: Shanghai International Holding Corp. GmbH(Europe)
UK responsible person: EDAN Medical (UK) Ltd
Unified social credit code: 914403001923672010
Exhibition record: CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Business registration

Registration status: Active
Incorporated: 1995-08-02
Registered capital: CNY 579,663,346
Paid-in capital: CNY 579,663,346
Legal form: Joint-stock limited company (listed)
Industry classification: Wholesale trade
Last approval date: 2025-12-01
Recognitions: National High-Tech EnterpriseTorch Programme enterpriseAbove-designated-size industrial enterprise
Listing: Listed on the A-share market

Business registration data from Tianyancha, as of 2026-09-02. 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

12007

32008

72009

82010

42011

62012

52013

22014

62015

92016

102017

62018

22019

22020

52021

22022

22023

52024

42025

32026

FDA listed device types

showing 8 of 56

System, Network And Communication, Physiological Monitors 1Detector And Alarm, Arrhythmia 1Electrocardiograph, Ambulatory (Without Analysis) 1Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) 1Electrode, Ion-Specific, Chloride 1Analyzer, Gas, Oxygen, Gaseous-Phase 1Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) 1Alarm, Blood-Pressure 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	国械注准20253220600	全自动恒温核酸扩增分析仪	Class III
CN	国械注准20253071984	病人监护仪	Class III
CN	国械注准20253070880	病人监护仪	Class III
CN	国械注准20253061136	便携式彩色超声诊断设备	Class III
EU	06944413840836	Trolley (for medical use)	Class I
EU	06944413837386	Endoscope Light Source	Class I
EU	06944413837379	Endoscope Light Source	Class I
EU	06944413837317	Endoscope Camera System	Class I
UK	64510	Holter ECG and ABP system	Class IIa
UK	31336	Blood Sampler	Class IIa
UK	44101	Central Monitoring System	Class IIa
US	K251508	Telemetry Monitor (iT30, iT50)	2026-08-06
US	K252463	SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)	2026-07-02
US	K251591	Holter ECG and ABP system (HolterABP)	2026-02-09
BR	80047300888	Analisador de gasometria e exames bioquímicos	Class II
BR	80047300603	Colposcópio em Vídeo	Class II
BR	80047309130	Sistema de Imagem para Diagnóstico por Ultrassom Digital	Class II
CA	77526	STRESS ECG	Class II
CA	77527	PC ECG	Class II
CA	77633	SMART ECG VIEWER DATA MANAGEMENT SOFTWARE	Class II