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Honsun (Nantong) Co., Ltd.

China · Shanghai · www.asian-medical.com

✓ Record-verifiedregistrations found in 8 marketsEU SRN CN-MF-000009428

This company has registrations in European Union, United States, United Kingdom, Brazil, Taiwan, South Korea, Australia, 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

94UDI-DI device records

Class I 67Class IIa 27

USUnited StatesFDA openFDA

9listed device types

Class I 4Class II 5Class III 0

plus 21 registration records and 12 510(k)

UKUnited KingdomMHRA PARD

12registered device records

Class I 9Class IIa 3

BRBrazilANVISA

35registered devices

Class I 22Class II 13

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

0active device licences

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

5GMP quality-system certificates

Business type not stated 1Import 4

AUAustraliaTGA ARTG

15active ARTG entries

Class I 8IIa 3Class Im (measuring) 4

HKHong KongMDACS

pendingnot queried

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 Union103 raw hits, 9 excluded, 94 confirmed

United States21 registration records, 12 510(k), 0 PMA, 1 excluded

United Kingdom12 confirmed, 1 excluded

Brazil35 confirmed, 1 excluded

Manufacturer names merged into this page: HONSUN (NANTONG) Co., Ltd. · HONSUN (NANTONG) CO. LTD · HONSUN (NANTONG) CO., LTD.

Regulatory identity

EU manufacturer SRN: CN-MF-000009428
EU authorised representative: Shanghai International Holding Corp. GmbH(Europe)
UK responsible person: Etheria Medical Ltd

FDA 510(k) clearances by year

12009

32013

22017

12018

12020

12021

12025

22026

FDA listed device types

showing 8 of 9

System, Measurement, Blood-Pressure, Non-Invasive 1Nebulizer (Direct Patient Interface) 1Generator, Oxygen, Portable 1Blood Pressure Cuff 1Compressor, Air, Portable 1Mask, Gas, Anesthetic 1Stethoscope, Manual 1Mouthpiece, Breathing 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	06970384252651	Stethoscope	Class I
EU	06970384255850	Stethoscope	Class I
EU	06970384252583	Stethoscope	Class I
EU	06970384253986	Stethoscope	Class I
UK	16156	Aneroid Sphygmomanometers	Class I
UK	45617	Blood Pressure Monitor	Class IIa
UK	41238	Penlight	Class I
US	K252399	Portable Oxygen Concentrator	2026-06-17
US	K260260	Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572 & LD-569)	2026-04-28
US	K251795	Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753)	2025-10-09
BR	10343209003	ESFIGMOMANÔMETRO CLÍNICO	Class II
BR	10343209023	GARROTE INCOTERM	Class I
BR	10332170029	ESTETOSCOPIO MEDICATE	Class I

Honsun (Nantong) Co., 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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