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ICU Medical

✓ Record-verifiedregistrations found in 11 marketsUnified social credit code 91310000MA1FY5GW5F

This company has registrations in United States, United Kingdom, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel — 11 overseas markets. No China NMPA registrations were found.

Registrations by market

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

CNChinaNMPA

0China registrations

as of 2026-09-01

EUEuropean UnionEUDAMED

0UDI-DI device records

USUnited StatesFDA openFDA

142listed device types

Class I 42Class II 100Class III 0

plus 903 registration records and 71 510(k)

UKUnited KingdomMHRA PARD

61registered device records

Class I 9Class IIa 41Class IIb 8Class III 3

BRBrazilANVISA

191registered devices

Class I 71Class II 120

229 including historic records

SASaudi ArabiaSFDA

2registered imported devices

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

CACanadaMDALL

62active device licences

Class II 56Class III 6

343 including historic records

TWTaiwanTFDA

40valid device licences

Class I 2Class II 38

SGSingaporeHSA SMDR

60device registrations

CLASS B 39CLASS C 18CLASS D 3

KRSouth KoreaMFDS GMP

3GMP quality-system certificates

Import 3

AUAustraliaTGA ARTG

67active ARTG entries

Class I 23IIa 36IIb 5Class Is (sterile) 3

HKHong KongMDACS

24valid listings

Class II 15Class III 8Class IV 1

ILIsraelAMAR

5registrations

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 Union7,190 raw hits, 100 excluded, 0 confirmed. Large result set — only the first 300 verified

United States903 registration records, 71 510(k), 0 PMA, 2 excluded

China0 certificates (Class III 0 / II 0 / I 0), as of 2026-09-01

United Kingdom61 confirmed, 17 excluded

Brazil191 confirmed, 0 excluded

Saudi Arabia2 confirmed, 0 excluded

Canada62 confirmed, 0 excluded

Manufacturer names merged into this page: ICU MEDICAL, INC · ICU MEDICAL, INC. · ICU Medical Czech Republic a. s. · ICU MEDICAL DE MEXICO, S. de R.L. de C.V. · ICU MEDICAL INC. · ICU MEDICAL DO BRASIL PRODUTOS HOSPITALARES LTDA

Regulatory identity

UK responsible person: ICU UK Medical Ltd
Unified social credit code: 91310000MA1FY5GW5F
Exhibition record: CMEF 89th (Apr 2024, Shanghai)

Business registration

Registration status: Active
Incorporated: 2017-01-22
Registered capital: USD 10,000,000
Paid-in capital: USD 8,000,000
Legal form: Limited liability company (wholly owned by a foreign corporation)
Industry classification: Wholesale trade
Last approval date: 2025-08-28
Recognitions: Micro and small 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

12000

12001

12003

42004

22005

22006

52007

42008

32009

22010

12013

12014

22016

12017

22018

12019

22020

32023

52025

32026

FDA listed device types

showing 8 of 142

Spirometer, Therapeutic (Incentive) 1Needle, Conduction, Anesthetic (W/Wo Introducer) 1Probe, Blood-Flow, Extravascular 1Port & Catheter, Implanted, Subcutaneous, Intravascular 1Device, Monitoring, Intracranial Pressure 1Cap, Device Disinfectant 1Tubes, Vials, Systems, Serum Separators, Blood Collection 1Syringe, Balloon Inflation 1

Registration details (sample)

Market	Identifier	Name	Class / date
UK	58977	Solution Only Gravity IV Set, Vented, Clave x1, 190 cm	Class IIa
UK	42750	MicroClave Clear Connector	Class IIa
UK	46102	Irrigation Set, Arthroscopy, Non-Vented Spike x2, Hand Pump, Click Clamp x3, Stepped Connector, Removable Silicone Tubing, 280 cm	Class I
US	K252130	LifeShield Infusion Safety Software Suite	2026-04-02
US	K252006	OTTO Disinfecting Cap	2026-03-27
US	K251980	ClaveQS Bag	2026-03-20
BR	80228990119	ESPIRÔMETRO EXERCITADOR RESPIRATÓRIO COACH - 2	Class I
BR	80228990104	Dispositivo de Aspiração de Ventilação Fechada SUCTION PRO 72	Class II
BR	80228990055	AGULHA DE SEGURANÇA GRIPPER MICRO II	Class II
SA	ME0000004061SFDAA00273	TRANSPAC™ Reusable Cable	—
SA	ME0000004061SFDAA00274	LOPEZ VALVE,TETHERED CAP, NON-STERILE	—
CA	4342	AEROMIST NEBULIZER	Class II
CA	8801	FLUID TRANSFER SETS	Class II
CA	11158	OXYGEN MASKS	Class II