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GCMEDICA ENTERPRISE Ltd. (WUXI)

China · Wuxi Jiangsu · www.gcmedica.com

✓ Record-verifiedregistrations found in 8 marketsEU SRN CN-MF-000008756

This company has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Australia, Hong Kong, Israel — 8 overseas markets. The China NMPA lookup is still pending.

Registrations by market

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

CNChinaNMPA

pendingnot queried

EUEuropean UnionEUDAMED

12UDI-DI device records

Class I 12

USUnited StatesFDA openFDA

54listed device types

Class I 38Class II 16Class III 0

plus 76 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

24registered device records

Class I 12Class IIa 12

BRBrazilANVISA

21registered devices

Class I 9Class II 12

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

SASaudi ArabiaSFDA

2registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

58active ARTG entries

Class I 6IIa 28Class Is (sterile) 24

HKHong KongMDACS

2valid listings

Class II 2

ILIsraelAMAR

26registrations

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 Union12 raw hits, 0 excluded, 12 confirmed

United States76 registration records, 2 510(k), 0 PMA

United Kingdom24 confirmed, 0 excluded

Brazil21 confirmed, 0 excluded

Saudi Arabia2 confirmed, 0 excluded

Manufacturer names merged into this page: GCMEDICA ENTERPRISE LTD.(WUXI) · GCMEDICA ENTERPRISE LTD. (WUXI) · GCMEDICA ENTERPRISE LTD. · GCMEDICA ENTERPRISE LTD.,(WUXI)

Regulatory identity

EU manufacturer SRN: CN-MF-000008756
EU authorised representative: Kingsmead Service B.V.
UK responsible person: KINGSMEAD SERVICE LIMITED

FDA 510(k) clearances by year

12019 · K182819

12025 · K251882

FDA listed device types

showing 8 of 54

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass 1Container, Sharps 1Trap, Sterile Specimen 1Catheter And Tip, Suction 1Collector, Urine, (And Accessories) For Indwelling Catheter 1Curette, Suction, Endometrial (And Accessories) 1Apparatus, Suction, Operating-Room, Wall Vacuum Powered 1Bottle, Collection, Vacuum 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	06974500613272	Pressure Infusion Bag	Class I
EU	06974500613265	Pressure Infusion Bag	Class I
EU	06974500613258	Bolsa de presión para infusión de	Class I
EU	06974500615238	Tubo Lavado Gástrico	Class I
UK	10749	Closed Suction Catheters	Class IIa
UK	36003	Arthroscopy Irrigation Sets	Class I
UK	16858	Heparin Caps	Class IIa
US	K251882	Uterine Aspiration Set	2025-10-16
US	K182819	Decanting Device	2019-12-02
BR	10150470417	Balão de Oxigênio em neoprene Goodcome	Class II
BR	10150470509	Sonda para nutrição enteral GC Médica	Class II
BR	10150479072	Capa Protetora para Manopla Estéril GC Medica	Class I
SA	ME0000018199SFDAA00003	GC Medica Isolation Gowns	—
SA	ME0000018199SFDAA00004	PRESSURE INFUSER BAG	—

GCMEDICA ENTERPRISE Ltd. (WUXI)

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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