Home›China›Shenzhen Comen Medical Instruments Co., Ltd.

Shenzhen Comen Medical Instruments Co., Ltd.

✓ Record-verifiedregistrations found in 13 marketsEU SRN CN-MF-000002236Unified social credit code 91440300738806174Y

This company holds 162 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 12 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

162China registrations

Class I 11Class II 89Class III 62

as of 2026-09-04

EUEuropean UnionEUDAMED

≥300UDI-DI device records

Class I 122Class IIa 46Class IIb 132

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

USUnited StatesFDA openFDA

24listed device types

Class I 0Class II 24Class III 0

plus 5 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

48registered device records

Class I 16Class IIa 8Class IIb 21Class III 3

BRBrazilANVISA

34registered devices

Class I 11Class II 23

86 including historic records

SASaudi ArabiaSFDA

3registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

23active ARTG entries

Class III 4IIa 8IIb 11

HKHong KongMDACS

11valid listings

Class II 2Class III 9

ILIsraelAMAR

20registrations

RURussiaRoszdravnadzor

33active registrations

Class 2a 7Class 2b 26

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 Union867 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified

United States5 registration records, 5 510(k), 0 PMA

China162 certificates (Class III 62 / II 89 / I 11), as of 2026-09-04

United Kingdom48 confirmed, 0 excluded

Brazil34 confirmed, 0 excluded

Saudi Arabia3 confirmed, 0 excluded

Manufacturer names merged into this page: SHENZHEN COMEN MEDICAL INSTRUMENTS CO., LTD. · Shenzhen Comen Medical Instruments Co., Ltd. · SHENZHEN COMEN MEDICAL INSTRUMENTS CO., LTD · SHENZHEN COMEN MEDICAL INSTRUMENTS CO.,LTD

Regulatory identity

EU manufacturer SRN: CN-MF-000002236
EU authorised representative: Lotus NL B.V.
UK responsible person: lotus global co ltd
Unified social credit code: 91440300738806174Y
Exhibition record: CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Business registration

Registration status: Active
Incorporated: 2002-05-17
Registered capital: CNY 12,000,000
Paid-in capital: CNY 12,000,000
Legal form: Limited liability company
Industry classification: Special-purpose equipment manufacturing
Last approval date: 2024-08-28
Recognitions: Micro and small enterpriseNational High-Tech EnterpriseAbove-designated-size industrial enterprise

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

12018 · K173454

12019 · K191106

12022 · K211619

22025 · K250854

FDA listed device types

showing 8 of 24

Detector And Alarm, Arrhythmia 1Index-Generating Electroencephalograph Software 1Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) 1Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) 1Analyzer, Gas, Oxygen, Gaseous-Phase 1Oximeter 1Electrode, Cutaneous 1Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	国械注准20263081144	呼吸机	Class III
CN	国械注准20263080340	体外除颤监护仪	Class III
CN	国械注准20263071823	颅内压传感器套件	Class III
CN	国械注准20263070666	病人监护仪	Class III
EU	06945429061024	Emergency and Transport Ventilator	Class IIb
EU	06945429061017	Emergency and Transport Ventilator	Class IIb
EU	06945429061000	Emergency and Transport Ventilator	Class IIb
EU	06945429060997	Emergency and Transport Ventilator	Class IIb
UK	34849	Anaesthetic Gas Scavenging System	Class IIa
UK	37710	Anaesthesia Machine	Class IIb
UK	13215	Infusion Pump	Class IIb
US	K250854	Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12); Multi-parameter Patient Monitor (N15); Multi-parameter Patient Monitor (N10MPro); Multi-parameter Patient Monitor (N12MPro); Multi-parameter Patient Monitor (N15MPro)	2025-12-17
US	K250190	Sequential Compression System (SCD600)	2025-12-08
US	K211619	Multi-Parameter Patient Monitor	2022-12-29
BR	80102513368	Luz cirúrgica móvel L9	Class I
BR	80102513369	Luz cirúrgica móvel	Class I
BR	80047309232	Oscilador de parede torácica de alta frequência	Class II
SA	ME0000010097SFDAA00015	LED Surgical Light	—
SA	ME0000010097SFDAA00014	Infant Bassinet	—