Home›China›Intersurgical

Intersurgical

✓ Record-verifiedregistrations found in 11 marketsEU SRN IT-MF-000010729Unified social credit code 913204115592541325

This company holds 9 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Hong Kong — 10 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 I 2Class II 7

as of 2026-09-04

EUEuropean UnionEUDAMED

≥300UDI-DI device records

Class IIa 285Class IIb 15

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

USUnited StatesFDA openFDA

35listed device types

Class I 26Class II 8Class III 0unclassified 1

plus 53 registration records and 22 510(k)

UKUnited KingdomMHRA PARD

87registered device records

Class I 15Class IIa 68Class IIb 3Custom-made 1

BRBrazilANVISA

127registered devices

Class I 6Class II 121

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

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

8active device licences

Class II 8

90 including historic records

TWTaiwanTFDA

3valid device licences

Class I 3

SGSingaporeHSA SMDR

35device registrations

CLASS B 35

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

90active ARTG entries

Class I 14IIa 74IIb 1Class Is (sterile) 1

HKHong KongMDACS

3valid listings

Class II 3

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 Union920 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified

United States53 registration records, 22 510(k), 0 PMA, 5 excluded

China9 certificates (Class III 0 / II 7 / I 2), as of 2026-09-04

United Kingdom87 confirmed, 0 excluded

Brazil127 confirmed, 3 excluded

Saudi Arabia1 confirmed, 0 excluded

Canada8 confirmed, 1 excluded

Manufacturer names merged into this page: INTERSURGICAL LTD. · INTERSURGICAL, INC. · INTERSURGICAL INCORPORATED · Intersurgical Limited

Regulatory identity

EU manufacturer SRN: IT-MF-000010729
EU authorised representative: UAB Intersurgical
UK responsible person: Intersurgical Ltd
Unified social credit code: 913204115592541325
Exhibition record: CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Business registration

Registration status: Active
Incorporated: 2010-08-31
Registered capital: GBP 15,600,000
Paid-in capital: GBP 15,600,000
Legal form: Limited liability company (wholly owned by a foreign corporation)
Industry classification: Pharmaceutical manufacturing
Last approval date: 2025-08-15

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

41991

21992

11993

31999

12003

12004

32010

22012

22013

12014

12015

12023

FDA listed device types

showing 8 of 35

Filter, Bacterial, Breathing-Circuit 1Catheter And Tip, Suction 1Spirometer, Diagnostic 1Nebulizer (Direct Patient Interface) 1Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase 1Valve, Non-Rebreathing 1Humidifier, Respiratory Gas, (Direct Patient Interface) 1Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	苏械注准20252081692	一次性使用输氧面罩	Class II
CN	苏械注准20252081517	一次性使用麻醉面罩	Class II
CN	苏械注准20252080693	一次性使用呼气末二氧化碳采集吸氧管	Class II
CN	苏械注准20242080377	一次性使用呼吸过滤器包	Class II
EU	08058323067240	—	Class IIa
EU	08058323066960	—	Class IIa
EU	08058323067028	—	Class IIa
EU	08058323066953	—	Class IIa
UK	32202	BREATHING SYSTEM FLEXIBLE TUBING	Class IIa
UK	35142	AEROSOL AND OXYGEN FACE MASKS	Class IIa
UK	10749	STERILE AND NON-STERILE TRACHEAL SUCTION SYSTEMS	Class IIa
US	K223258	TNI Clear-Guard 3 angled breathing filter (1545020)	2023-06-15
US	K141087	INTER-THERM PEDIATRIC HMEF, INTERN-THERM MINI PEDIATRIC ANGLED HMEF	2015-02-12
US	K132143	EXHALATION VALVE	2014-06-04
BR	82737659138	Filtro Respiratório Intersurgical Hydro-Guard	Class II
BR	82737659133	Nebulizadores Cirrus Intersurgical	Class II
BR	82737659134	Nebulizadores Cirrus2 modelo AC	Class II
SA	ME0000011616SFDAA00564	NFLOW infant bonnet	—
CA	62246	BREATHING SYSTEM TUBING	Class II
CA	77545	HUMIDIFIER NEBULIZER	Class II
CA	4151	BREATHING CIRCUIT SYSTEM	Class II

Intersurgical

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)

Similar companies