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Hony Medical Co., Ltd.

China · Taishan Guangdong · www.yafho.com

✓ Record-verifiedregistrations found in 9 marketsEU SRN CN-MF-000008239Unified social credit code 91440781090117236X

This company holds 31 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, South Korea, Australia, Israel — 8 overseas markets.

Registrations by market

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

CNChinaNMPA

31China registrations

Class I 12Class II 19

as of 2026-09-04

EUEuropean UnionEUDAMED

110UDI-DI device records

Class I 110

USUnited StatesFDA openFDA

10listed device types

Class I 7Class II 3Class III 0

plus 14 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

4registered device records

Class I 4

BRBrazilANVISA

10registered devices

Class I 9Class II 1

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

SASaudi ArabiaSFDA

9registered 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

2GMP quality-system certificates

Import 1Manufacturing 1

AUAustraliaTGA ARTG

2active ARTG entries

Class Is (sterile) 2

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 Union146 raw hits, 36 excluded, 110 confirmed

United States14 registration records, 4 510(k), 0 PMA

China31 certificates (Class III 0 / II 19 / I 12), as of 2026-09-04

United Kingdom4 confirmed, 3 excluded

Brazil10 confirmed, 0 excluded

Saudi Arabia9 confirmed, 0 excluded

Manufacturer names merged into this page: HONY MEDICAL CO., LTD · HONY MEDICAL CO., LTD. · Hony Medical Co., Ltd.

Regulatory identity

EU manufacturer SRN: CN-MF-000008239
EU authorised representative: Lotus NL B.V.
UK responsible person: It's Interventional Regulatory Limited
Unified social credit code: 91440781090117236X
Exhibition record: CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Business registration

Registration status: Active
Incorporated: 2013-12-30
Registered capital: CNY 20,000,000
Paid-in capital: CNY 20,000,000
Legal form: Limited liability company (natural-person invested or controlled)
Industry classification: Special-purpose equipment manufacturing
Last approval date: 2026-02-25
Recognitions: Micro and small enterpriseNational High-Tech EnterpriseSRDI SME

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

12022 · K221999

12023 · K221278

22024 · K241789

FDA listed device types

showing 8 of 10

Drape, Adhesive, Aerosol 1Accessory, Surgical Apparel 1Holder, Ureteral Catheter 1Device, Fixation, Tracheal Tube 1Dressing, Wound, Hydrophilic 1Tape And Bandage, Adhesive 1Dressing, Wound, Hydrogel Without Drug And/Or Biologic 1Media, Coupling, Ultrasound 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	粤械注准20252140549	封闭式负压引流敷料套装	Class II
CN	粤械注准20242141164	婴儿光疗防护眼罩	Class II
CN	粤械注准20242140835	硅凝胶敷贴	Class II
CN	粤械注准20232141931	医用水凝胶敷料	Class II
EU	06975284216864	EZLOCK	Class I
EU	16975284216472	STERILE INSTRUMENT COVER	Class I
EU	16970747768598	STERILE INSTRUMENT COVER	Class I
EU	16970747760653	STERILE INSTRUMENT COVER	Class I
UK	16866	Surgical Tape	Class I
UK	44714	Intraoperative ultrasound imaging transducer cover	Class I
UK	47783	Surgical Drape	Class I
US	K241789	Non-Sterile Ultrasound Transmission Gels	2024-07-24
US	K241615	Transducer Probe Cover	2024-07-03
US	K221278	Transducer Probe Cover	2023-01-11
BR	80146010011	RIODERM I.V. SOLUTION CURATIVO DE FIXAÇÃO I.V.	Class I
BR	80146010012	RIODERM I.V. SOLUTION COBERTURA DE FIXAÇÃO I.V.	Class I
BR	81194860018	Fixador de Tubo Medfix Advance Block	Class I
SA	ME0000021316SFDAA00012	Non woven Surgi-fix	—
SA	ME0000021316SFDAA00016	Silk tape	—

Hony Medical Co., Ltd.

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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