Home›China›HANGZHOU ALLTEST BIOTECH CO.,LTD

HANGZHOU ALLTEST BIOTECH CO.,LTD

China · 杭州 · www.alltests.com.cn/Index.asp

✓ Record-verifiedregistrations found in 13 marketsEU SRN CN-MF-000010710Unified social credit code 91330101685842840Y

This company holds 44 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

44China registrations

Class II 22Class III 22

as of 2026-09-04

EUEuropean UnionEUDAMED

≥300UDI-DI device records

IVD general 288ivd-annex-ii-list-a 4ivd-devices-self-testing 8

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

USUnited StatesFDA openFDA

48listed device types

Class I 10Class II 36Class III 0unclassified 2

plus 108 registration records and 14 510(k)

UKUnited KingdomMHRA PARD

257registered device records

IVD A 7IVD B 1IVD C 5IVD general 208Class C – Self-testing or Near-patient Testing 8IVD Annex II List A 4IVD Annex II List B 7IVD Devices for Self-Testing 17

BRBrazilANVISA

143registered devices

Class I 2Class II 141

275 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

7active device licences

Class II 7

129 including historic records

TWTaiwanTFDA

9valid device licences

Class I 9

SGSingaporeHSA SMDR

17device registrations

CLASS B 11CLASS C 1CLASS D 5

KRSouth KoreaMFDS GMP

6GMP quality-system certificates

Business type not stated 2IVD import 4

AUAustraliaTGA ARTG

30active ARTG entries

IVD Class 1 2IVD Class 2 19IVD Class 3 8IVD Class 4 1

HKHong KongMDACS

14valid listings

IVD B 3IVD C 9IVD D 2

ILIsraelAMAR

32registrations

RURussiaRoszdravnadzor

30active registrations

Class 2a 22Class 2b 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 Union2,730 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified

United States108 registration records, 14 510(k), 0 PMA

China44 certificates (Class III 22 / II 22 / I 0), as of 2026-09-04

United Kingdom257 confirmed, 0 excluded

Brazil143 confirmed, 0 excluded

Canada7 confirmed, 0 excluded

Manufacturer names merged into this page: Hangzhou AllTest Biotech Co.,Ltd · HANGZHOU ALLTEST BIOTECH CO., LTD. · HANGZHOU ALLTEST BIOTECH CO. LTD · HANGZHOU ALLTEST BIOTECH CO., LTD

Regulatory identity

EU manufacturer SRN: CN-MF-000010710
EU authorised representative: MedNet EC-REP GmbH
UK responsible person: Medimap Ltd
Unified social credit code: 91330101685842840Y
Exhibition record: CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Business registration

Registration status: Active
Incorporated: 2009-04-17
Registered capital: CNY 79,280,855
Paid-in capital: CNY 79,280,855
Legal form: Joint-stock limited company (listed)
Industry classification: Pharmaceutical manufacturing
Last approval date: 2023-08-16
Recognitions: National High-Tech EnterpriseSRDI SMEInnovative SMEAbove-designated-size industrial enterprise
Listing: Listed on the STAR Market

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

12019

12022

32023

32024 · K242540

52025 · K252607

12026 · K260342

FDA listed device types

showing 8 of 48

Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) 1Dye-Indicator, Ph (Urinary, Non-Quantitative) 1Test System, Nicotine, Cotinine, Metabolites 1Test, Luteinizing Hormone (Lh), Over The Counter 1Test, Follicle Stimulating Hormone (Fsh), Over The Counter 1Paper, Obstetric Ph 1Culture Media, Non-Propagating Transport 1Test, Urine Leukocyte 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	国械注准20263401730	丙型肝炎病毒抗体检测试剂盒（免疫层析法）	Class III
CN	国械注准20253402543	乙型肝炎病毒表面抗原检测试剂盒（免疫层析法）	Class III
CN	国械注准20253400790	人类免疫缺陷病毒抗体、梅毒螺旋体抗体、乙型肝炎病毒表面抗原、丙型肝炎病毒抗体联合检测试剂盒（胶体金法）	Class III
CN	国械注准20243402107	ABO血型正定型和RhD血型定型检测试剂盒（固相法）	Class III
EU	07427254527504	Ferritin Rapid test	ivd-devices-self-testing
EU	06942598239674	Hexagon HCV	ivd-annex-ii-list-a
EU	06942598246221	MPRD Rapid Test	IVD general
EU	06942598205570	KET Rapid Test	IVD general
UK	42656	EDDP Rapid Test Cassette	IVD general
UK	64154	6-Monoacetylmorphine(6-MAM) Rapid Test	IVD general
UK	67265	ABO and RhD Blood Grouping Rapid Test Cassette	IVD Annex II List A
US	K260342	AllTest Strep A Rapid Test	2026-04-30
US	K252607	AllTest Urinary Tract Infection Test	2025-10-30
US	K251053	Shinetell PlusTM Digital Early Pregnancy Test	2025-07-15
BR	80638720243	HMPV Rapid Test	Class II
BR	80105220177	FASTLINE FIA READER (FFR 1111)	Class II
BR	80105220267	FASTLINE READER	Class II
CA	103340	ZOP50 RAPID TEST PANEL (URINE)	Class II
CA	109165	ALCOHOL RAPID TEST CASSETTE (URINE)	Class II
CA	109749	XYLAZINE (XYL)1000 RAPID TEST CASSETTE (URINE)	Class II