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GLOBALCARE MEDICAL TECHNOLOGY HK, LTD.

Hong Kong, China SAR · Hong Kong · www.globalcare.com.hk

✓ Record-verifiedregistrations found in 6 marketsEU SRN CN-MF-000033595Unified social credit code 914420000826348231

This company has registrations in European Union, United States, United Kingdom, Saudi Arabia, South Korea, Israel — 6 overseas markets. The China NMPA lookup is still pending.

Registrations by market

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

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

147UDI-DI device records

Class IIa 147

USUnited StatesFDA openFDA

9listed device types

Class I 1Class II 8Class III 0

plus 20 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

5registered device records

Class IIa 5

BRBrazilANVISA

0registered devices

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

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

3GMP quality-system certificates

Business type not stated 2Import 1

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

4registrations

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 Union147 raw hits, 0 excluded, 147 confirmed

United States20 registration records, 5 510(k), 0 PMA, 3 excluded

United Kingdom5 confirmed, 0 excluded

Saudi Arabia1 confirmed, 0 excluded

Manufacturer names merged into this page: GLOBALCARE MEDICAL TECHNOLOGY CO., LTD · Globalcare Medical Technology HK, Ltd. · Globalcare Medical Technology Co., Ltd

Regulatory identity

EU manufacturer SRN: CN-MF-000033595
EU authorised representative: Donawa Lifescience Consulting Srl
UK responsible person: Donawa Lifescience Ltd
Unified social credit code: 914420000826348231
Exhibition record: Rehab & Elderly Care Expo (Spring 2026, Shanghai)

FDA 510(k) clearances by year

22020 · K192633

12022 · K222160

12025 · K250136

12026 · K253896

FDA listed device types

showing 8 of 9

Lamp, Infrared, Therapeutic Heating 1Stimulator, Nerve, Transcutaneous, Over-The-Counter 1System, Measurement, Blood-Pressure, Non-Invasive 1Nebulizer (Direct Patient Interface) 1Stimulator, Muscle, Powered, For Muscle Conditioning 1Pump, Breast, Powered 1Blood Pressure Cuff 1Lung Sound Monitor 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	06970229255472	NEB PRO	Class IIa
EU	06970229255434	EMSER Inhalator Pro	Class IIa
EU	06970229254987	NEB 950	Class IIa
EU	06970229254963	NEB 650	Class IIa
UK	45617	Blood pressure monitor	Class IIa
UK	35457	Aerosoltherapy Nebulizer	Class IIa
UK	35457	Aerosoltherapy Nebulizer	Class IIa
US	K253896	TENS/EMS device (GUSE01)	2026-03-04
US	K250136	Globalcare Blood Pressure Monitor (GUS610)	2025-04-08
US	K222160	GUS610 Blood pressure monitor	2022-11-22
SA	ME0000011704SFDAA00001	BC100 Soft	—

GLOBALCARE MEDICAL TECHNOLOGY HK, LTD.

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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