Home›China›Acon Biotech (Hangzhou) Co., Ltd.

Acon Biotech (Hangzhou) Co., Ltd.

✓ Record-verifiedregistrations found in 11 marketsEU SRN CN-MF-000006977Unified social credit code 913301006091684447

This company holds 193 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Taiwan, Singapore, South Korea, Australia, Israel, Russia — 10 overseas markets. EU UDI-DI records ≥281, the first 300 verified individually.

Registrations by market

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

CNChinaNMPA

193China registrations

Class I 4Class II 135Class III 54

as of 2026-09-04

EUEuropean UnionEUDAMED

≥281UDI-DI device records

IVD general 281

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

USUnited StatesFDA openFDA

29listed device types

Class I 18Class II 10Class III 0unclassified 1

plus 27 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

15registered device records

IVD general 14IVD Devices for Self-Testing 1

BRBrazilANVISA

26registered devices

Class I 2Class II 24

34 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

2valid device licences

Class I 1Class II 1

SGSingaporeHSA SMDR

7device registrations

CLASS B 4CLASS C 1CLASS D 2

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

IVD import 1

AUAustraliaTGA ARTG

2active ARTG entries

IVD Class 3 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

8active registrations

Class 2a 5Class 3 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 Union3,493 raw hits, 19 excluded, 281 confirmed. Large result set — only the first 300 verified

United States27 registration records, 0 510(k), 0 PMA, 4 excluded

China193 certificates (Class III 54 / II 135 / I 4), as of 2026-09-04

United Kingdom15 confirmed, 9 excluded

Brazil26 confirmed, 2 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: ACON BIOTECH (HANGZHOU) CO., LTD. · Acon Biotech (Hangzhou) Co., Ltd. · ACON BIOTECH (HANGZHOU) CO.,LTD. · ACON BIOTECH (HANGZHOU)CO.,LTD. · ACON BIOTECH (HANGZHOU) CO.,LTD · ACON BIOTECH (HANGZHOU) CO., LTD

Regulatory identity

EU manufacturer SRN: CN-MF-000006977
EU authorised representative: MedNet EC-REP GmbH
UK responsible person: Medimap Ltd
Unified social credit code: 913301006091684447
Exhibition record: CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Business registration

Registration status: Active
Incorporated: 1995-05-02
Registered capital: USD 9,500,000
Paid-in capital: USD 9,500,000
Legal form: Limited liability company (wholly owned by a foreign corporation)
Industry classification: Pharmaceutical manufacturing
Last approval date: 2024-01-12
Recognitions: National High-Tech EnterpriseSRDI SMEAbove-designated-size industrial 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 listed device types

showing 8 of 29

Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) 1Dye-Indicator, Ph (Urinary, Non-Quantitative) 1Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) 1Urinalysis Controls (Assayed And Unassayed) 1Automated Urinalysis System 1Test, Luteinizing Hormone (Lh), Over The Counter 1Test, Nitrite, Urinary, Non-Quantitative, Over The Counter 1Calculator/Data Processing Module, For Clinical Use 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	国械注准20263401086	甲型/乙型流感病毒抗原检测试剂盒（乳胶法）	Class III
CN	国械注准20263401028	腺病毒抗原检测试剂盒（乳胶法）	Class III
CN	国械注准20263400861	呼吸道合胞病毒抗原检测试剂盒（乳胶法）	Class III
CN	国械注准20253402371	幽门螺杆菌抗体检测试剂（荧光免疫分析法）	Class III
EU	D-CNMF000006977031137a4J	QUIK-CHECK	IVD general
EU	D-CNMF000006977034097a6A	QUIK-CHECK	IVD general
EU	D-CNMF000006977031107b45	QUIK-CHECK	IVD general
EU	D-CNMF000006977034027d5D	QUIK-CHECK	IVD general
UK	62946	Flowflex Dengue NS1 Antigen Rapid Test Cassette(Serum/Plasma/Whole Blood)	IVD general
UK	62928	Flowflex Dengue NS1 Ag & IgG/IgM Combo Rapid Test Cassette (Serum/Plasma/Whole Blood)	IVD general
UK	63238	Flowflex Dengue IgG/IgM Rapid Test Cassette(Serum/Plasma/Whole Blood)	IVD general
BR	80915630031	FORESIGHT LH EIA TEST KIT	Class II
BR	80915630032	FORESIGHT hCG EIA TEST KIT	Class II
BR	80915630033	FORESIGHT PRL EIA TEST KIT	Class II