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Huizhou Foryou Medical Devices Co., Ltd.

China · Huizhou Guangdong · www.foryoumedical.com

✓ Record-verifiedregistrations found in 13 marketsEU SRN CN-MF-000007344

This company has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 13 overseas markets. EU UDI-DI records ≥144, the first 300 verified individually. 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

≥144UDI-DI device records

Class I 3Class IIb 141

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

USUnited StatesFDA openFDA

17listed device types

Class I 12Class II 1Class III 0unclassified 4

plus 37 registration records and 23 510(k)

UKUnited KingdomMHRA PARD

52registered device records

Class I 21Class IIa 1Class IIb 30

BRBrazilANVISA

6registered devices

Class I 5Class II 1

14 including historic records

SASaudi ArabiaSFDA

2registered imported devices

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

CACanadaMDALL

0active device licences

13 including historic records

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

1device registrations

CLASS C 1

KRSouth KoreaMFDS GMP

7GMP quality-system certificates

Business type not stated 1Import 5Manufacturing 1

AUAustraliaTGA ARTG

22active ARTG entries

Class I 3IIa 3IIb 15Class Is (sterile) 1

HKHong KongMDACS

3valid listings

Class III 3

ILIsraelAMAR

12registrations

RURussiaRoszdravnadzor

4active registrations

Class 2b 4

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 Union1,260 raw hits, 156 excluded, 144 confirmed. Large result set — only the first 300 verified

United States37 registration records, 23 510(k), 0 PMA, 2 excluded

United Kingdom52 confirmed, 6 excluded

Brazil6 confirmed, 0 excluded

Saudi Arabia2 confirmed, 0 excluded

Manufacturer names merged into this page: HUIZHOU FORYOU MEDICAL DEVICES CO.,LTD. · HuiZhou Foryou Medical Devices Co., LTD. · HUIZHOU FORYOU MEDICAL DEVICES CO., LTD. · HUIZHOU FORYOU MEDICAL DEVICES CO., LTD · HUIZHOU FORYOU MEDICAL DEVICES CO LTD · Huizhou Foryou Medical Devices Co., Ltd.

Regulatory identity

EU manufacturer SRN: CN-MF-000007344
EU authorised representative: Shanghai International Holding Corp. GmbH(Europe)
UK responsible person: KINGSMEAD SERVICE LIMITED

FDA 510(k) clearances by year

12012

22013

22015

12016

12017

22018

22021

32022

12023

62024

12025

12026

FDA listed device types

showing 8 of 17

Dressing, Wound, Drug 1Oral Wound Dressing 1Wound Dressing With Animal-Derived Material(S) 1Hemostatic Wound Dressing Without Thrombin Or Other Biologics 1Closure, Wound, Adhesive 1Burr, Corneal, Battery Powered, Rust Ring Removal 1Device, Fixation, Tracheal Tube 1Dressing, Wound, Occlusive 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	26940610113487	—	Class IIb
EU	26940610113494	—	Class IIb
EU	26940610113579	—	Class IIb
EU	26940610113593	—	Class IIb
UK	16866	Catheter Fixation Device	Class I
UK	58749	LUOFUCON® Silicone Tape	Class I
UK	33468	SUNTOUCH® Medical Spongs	Class I
US	K252028	LUOFUCON® Antimicrobial Wound Gel	2026-03-11
US	K250642	LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)	2025-11-19
US	K240809	LUOFUCON® Silver Collagen Dressing	2024-12-16
BR	81926090007	KELOGEL SILICONE	Class I
BR	81556000001	NASAL DRESSING	Class I
BR	82983220001	FITA / PLACA DE SILICONE KELOGEL	Class I
SA	ME0000000501SFDAA00001	LUOFUCON® Silicone Scar Gel Sheet	—
SA	ME0000003757SFDAA00002	Vision	—