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Zhejiang Hongyu Medical Commodity Co., Ltd.

✓ Record-verifiedregistrations found in 10 marketsEU SRN CN-MF-000008204Unified social credit code 91330782734538344Y

This company holds 17 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Taiwan, Australia, Israel, Russia — 9 overseas markets. EU UDI-DI records ≥236, the first 300 verified individually.

Registrations by market

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

CNChinaNMPA

17China registrations

Class I 5Class II 12

as of 2026-09-04

EUEuropean UnionEUDAMED

≥236UDI-DI device records

Class I 235Class IIa 1

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

USUnited StatesFDA openFDA

36listed device types

Class I 33Class II 2Class III 0unclassified 1

plus 36 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

33registered device records

Class I 28Class IIa 3Class IIb 2

BRBrazilANVISA

6registered devices

Class I 6

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

SASaudi ArabiaSFDA

26registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

22active ARTG entries

Class I 8Class Is (sterile) 14

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

4registrations

RURussiaRoszdravnadzor

1active registrations

Class 1 1

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 Union542 raw hits, 64 excluded, 236 confirmed. Large result set — only the first 300 verified

United States36 registration records, 1 510(k), 0 PMA, 8 excluded

China17 certificates (Class III 0 / II 12 / I 5), as of 2026-09-04

United Kingdom33 confirmed, 1 excluded

Brazil6 confirmed, 4 excluded

Saudi Arabia26 confirmed, 0 excluded

Manufacturer names merged into this page: ZHEJIANG HONGYU MEDICAL COMMODITY CO., LTD. · ZHEJIANG HONGYU MEDICAL COMMODITY CO., LTD · Zhejiang Hongyu Medical Commodity Co., Ltd. · Zhejiang Hongyu Medical Commodity Co Ltd · zhejiang Hongyu Medical Commodity Co.,Ltd

Regulatory identity

EU manufacturer SRN: CN-MF-000008204
EU authorised representative: RIOMAVIX SOCIEDAD LIMITADA
UK responsible person: SUNGO Certification Company Limited
Unified social credit code: 91330782734538344Y
Exhibition record: CMEF 93rd (Apr 2026, Shanghai)

Business registration

Registration status: Active
Incorporated: 2002-01-09
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: Pharmaceutical manufacturing
Last approval date: 2025-08-15
Recognitions: Micro and small enterpriseNational High-Tech 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

12021 · K211897

FDA listed device types

showing 8 of 36

Mask, Surgical 1Continuous Measurement Thermometer 1Pad, Eye 1Forceps 1Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use 1First Aid Kit Without Drug 1Adhesive Backed Thermal Skin Patches 1Bedding, Disposable, Medical 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	浙械注准20262140372	聚氨酯泡沫敷料	Class II
CN	浙械注准20252141759	藻酸盐敷料	Class II
CN	浙械注准20242141000	水胶体敷料	Class II
CN	浙械注准20232141140	医用一次性防护服	Class II
EU	06938056234268	Nasal Strips	Class I
EU	06938056234251	Nasal Strips	Class I
EU	06938056234244	Nasal Strips	Class I
EU	06938056234237	Nasal Strips	Class I
UK	61850	Super Absorbent Pad	Class I
UK	34864	Wound Dressing	Class I
UK	34864	Wound Dressing	Class I
US	K211897	Surgical Face Mask	2021-08-03
BR	80836760003	Conkofix	Class I
BR	80465070008	ATADURA ELÁSTICA DE MÉDIA COMPRESSÃO CLEARPASSAGE	Class I
BR	80836760001	CONKOSCAR CARE	Class I
SA	ME0000005699SFDAA00003	Disposable Medical Face Mask	—
SA	ME0000005699SFDAA00004	Razimed	—

Zhejiang Hongyu Medical Commodity 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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