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Grandway Technology (Shenzhen) Limited

✓ Record-verifiedregistrations found in 5 marketsEU SRN CN-MF-000009310Unified social credit code 914403007412394063

This company holds 2 NMPA certificates in China and has registrations in European Union, United States, Canada, South Korea — 4 overseas markets.

Registrations by market

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

CNChinaNMPA

2China registrations

Class II 2

as of 2026-09-04

EUEuropean UnionEUDAMED

112UDI-DI device records

Class IIa 112

USUnited StatesFDA openFDA

6listed device types

Class I 1Class II 5Class III 0

plus 27 registration records and 21 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

2active device licences

Class II 2

4 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

6GMP quality-system certificates

Business type not stated 1Import 5

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

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 Union112 raw hits, 0 excluded, 112 confirmed

United States27 registration records, 21 510(k), 0 PMA

China2 certificates (Class III 0 / II 2 / I 0), as of 2026-09-04

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED

Regulatory identity

EU manufacturer SRN: CN-MF-000009310
EU authorised representative: MedNet EC-REP GmbH
Unified social credit code: 914403007412394063
Exhibition record: CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Business registration

Registration status: Active
Incorporated: 2002-09-30
Registered capital: HKD 12,000,000
Paid-in capital: HKD 10,465,500
Industry classification: Instruments and meters manufacturing
Last approval date: 2022-10-17
Recognitions: Micro and small 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

12011

42013

42014

72015

32017

12018

12019

FDA listed device types

Sleeve, Limb, Compressible 1System, Measurement, Blood-Pressure, Non-Invasive 1Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat 1Massager, Powered Inflatable Tube 1Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat 1Massager, Therapeutic, Electric 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	粤械注准20242071780	臂式电子血压计	Class II
CN	粤械注准20222071660	臂式电子血压计	Class II
EU	04895045404977	Digital Automatic Blood Pressure Monitor - MD5100	Class IIa
EU	04895045404885	Digital Automatic Blood Pressure Monitor - MD1910	Class IIa
EU	04895045403437	Digital Automatic Blood Pressure Monitor - MD3011	Class IIa
EU	04895045403420	Digital Automatic Blood Pressure Monitor MD3010	Class IIa
US	K191593	Digital Automatic Blood Pressure Monitor MD36 Series	2019-07-22
US	K171379	Digital Automatic Wrist Blood Pressure Monitor MD4300	2018-04-10
US	K163648	Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic Blood Pressure Monitor BPM45 Series	2017-07-07
CA	95724	BLOOD PRESSURE MONITOR	Class II
CA	95794	BLOOD PRESSURE MONITOR	Class II

Grandway Technology (Shenzhen) Limited

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)

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