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Tianjin Huahong Technology Co.,Ltd.

✓ Record-verifiedregistrations found in 13 marketsEU SRN CN-MF-000015849Unified social credit code 911201165661306999

This company holds 13 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 12 overseas markets. EU UDI-DI records ≥300, the first 300 verified individually.

Registrations by market

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

CNChinaNMPA

13China registrations

Class I 4Class II 4Class III 5

as of 2026-09-04

EUEuropean UnionEUDAMED

≥300UDI-DI device records

Class I 9Class IIa 290Class IIb 1

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

USUnited StatesFDA openFDA

6listed device types

Class I 1Class II 5Class III 0

plus 16 registration records and 14 510(k)

UKUnited KingdomMHRA PARD

18registered device records

Class I 2Class IIa 15IVD general 1

BRBrazilANVISA

66registered devices

Class I 11Class II 55

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

1active device licences

Class II 1

11 including historic records

TWTaiwanTFDA

22valid device licences

Class I 22

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

5GMP quality-system certificates

Business type not stated 1Import 4

AUAustraliaTGA ARTG

5active ARTG entries

IIa 5

HKHong KongMDACS

3valid listings

Class II 3

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

3active registrations

Class 2a 3

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 Union618 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified

United States16 registration records, 14 510(k), 0 PMA

China13 certificates (Class III 5 / II 4 / I 4), as of 2026-09-04

United Kingdom18 confirmed, 0 excluded

Brazil66 confirmed, 1 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: Tianjin Huahong Technology Co., Ltd. · TIANJIN HUAHONG TECHNOLOGY CO., LTD. · TIANJIN HUAHONG MEDICAL CO., LTD. · Tianjin Huahong Tecnology Co., Ltd

Regulatory identity

EU manufacturer SRN: CN-MF-000015849
EU authorised representative: Shanghai International Holding Corp. GmbH(Europe)
UK responsible person: CMC Medical Devices LTD
Unified social credit code: 911201165661306999
Exhibition record: CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Business registration

Registration status: Active
Incorporated: 2010-12-28
Registered capital: CNY 50,169,240
Paid-in capital: CNY 20,000,000
Legal form: Limited liability company
Industry classification: Special-purpose equipment manufacturing
Last approval date: 2026-04-14
Recognitions: National High-Tech EnterpriseTechnology-based SMESRDI SMEGazelle enterpriseRecognised enterprise technology centreAbove-designated-size industrial enterprise
Listing: Delisted from the NEEQ

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

42022

32024 · K243306

22025 · K253706

42026 · K260845

FDA listed device types

Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature 1Needle, Acupuncture, Single Use 1Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature 1Multiple Use Blood Lancet For Single Patient Use Only 1Needle, Hypodermic, Single Lumen 1Applier, Surgical, Clip 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	国械注准20263021538	一次性使用不可吸收结扎夹	Class III
CN	国械注准20253142310	一次性使用无菌注射针	Class III
CN	国械注准20253141852	一次性使用自毁型注射笔用针头	Class III
CN	国械注准20253141346	一次性使用注射笔用针头	Class III
EU	06957138618031	—	Class IIa
EU	06957138617638	—	Class IIa
EU	06957138617423	—	Class I
EU	06957138617300	—	Class IIa
UK	44127	Pen needle	Class IIa
UK	44127	Pen needle	Class IIa
UK	44127	Pen needle	Class IIa
US	K260845	Huahong Sharps Container (HHR-I, HHR-II)	2026-08-05
US	K262211	Lancet	2026-07-22
US	K260191	Safety lancet (XXXVII)	2026-03-31
BR	10098710041	Agulhas para Acupuntura Estéreis Descartáveis - Testline	Class II
BR	80788620001	LANCETAS DE SEGURANÇA	Class II
BR	80788620002	Lancetas	Class II
CA	92660	READYLANCE PRESSURE ACTIVATED SAFETY LANCETS	Class II