Home›China›Zhejiang Orient Gene Biotech Co.,Ltd

Zhejiang Orient Gene Biotech Co.,Ltd

✓ Record-verifiedregistrations found in 9 marketsEU SRN CN-MF-000017965Unified social credit code 913305007804719612

This company holds 82 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Singapore, Hong Kong, Israel, Russia — 8 overseas markets. EU UDI-DI records ≥210, the first 300 verified individually.

Registrations by market

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

CNChinaNMPA

82China registrations

Class I 4Class II 59Class III 19

as of 2026-09-04

EUEuropean UnionEUDAMED

≥210UDI-DI device records

IVD A 4IVD B 12IVD C 26IVD general 167ivd-devices-self-testing 1

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

USUnited StatesFDA openFDA

86listed device types

Class I 34Class II 45Class III 0unclassified 7

plus 89 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

74registered device records

IVD general 66Class C – Self-testing or Near-patient Testing 1IVD Annex II List B 3IVD Devices for Self-Testing 3System or Procedure Pack 1

BRBrazilANVISA

45registered devices

Class I 5Class II 40

95 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

2device registrations

CLASS C 1CLASS D 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

1valid listings

IVD C 1

ILIsraelAMAR

10registrations

RURussiaRoszdravnadzor

1active registrations

Class 2a 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 Union843 raw hits, 90 excluded, 210 confirmed. Large result set — only the first 300 verified

United States89 registration records, 1 510(k), 0 PMA, 6 excluded

China82 certificates (Class III 19 / II 59 / I 4), as of 2026-09-04

United Kingdom74 confirmed, 1 excluded

Brazil45 confirmed, 0 excluded

Saudi Arabia0 confirmed, 1 excluded

Manufacturer names merged into this page: ZHEJIANG ORIENT GENE BIOTECH · ZHEJIANG ORIENT GENE BIOTECH CO., LTD. · ZHEJIANG ORIENT GENE BIOTECH CO, LTD.

Regulatory identity

EU manufacturer SRN: CN-MF-000017965
EU authorised representative: CMC Medical Devices & Drugs SL
UK responsible person: SENSUS Group Ltd
Unified social credit code: 913305007804719612
Exhibition record: CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Business registration

Registration status: Active
Incorporated: 2005-12-01
Registered capital: CNY 201,600,000
Paid-in capital: CNY 201,600,000
Legal form: Joint-stock limited company (foreign-invested, listed)
Industry classification: Pharmaceutical manufacturing
Last approval date: 2026-07-09
Recognitions: National High-Tech EnterpriseTorch Programme enterpriseAbove-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

12011 · K110309

FDA listed device types

showing 8 of 86

Colorimeter, Photometer, Spectrophotometer For Clinical Use 1Test, Luteinizing Hormone (Lh), Over The Counter 1Container, Specimen, Sterile 1Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) 1Test, Follicle Stimulating Hormone (Fsh), Over The Counter 1Enzyme Immunoassay, Nicotine And Nicotine Metabolites 1Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use 1Refractometer For Clinical Use 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	国械注准20263401676	梅毒螺旋体抗体检测试剂（胶体金法）	Class III
CN	国械注准20263401043	幽门螺杆菌（H.P）抗原检测试剂（乳胶法）	Class III
CN	国械注准20263400707	丙型肝炎病毒（HCV）抗体检测试剂（胶体金法）	Class III
CN	国械注准20253402221	肺炎支原体抗原检测试剂盒（乳胶法）	Class III
EU	D-EZW1-S-20CD	Easy @ Home® Pregnancy Test	ivd-devices-self-testing
EU	06950996049535	CRP Quantitative Test Kit (Time-Resolved FIA)	IVD B
EU	06950996096065	25-OH-VD Quantitative Test Kit (Time-Resolved FIA)	IVD B
EU	06950996058018	HbA1c Quantitative Test Kit (Time-Resolved FIA)	IVD C
UK	49856	ADENOVIRUS Rapid Test Cassette (Faeces)	IVD general
UK	65991	TOTAL IgE Rapid Test	IVD general
UK	63981	ALPHA-FETOPROTEIN Rapid Test	IVD general
US	K110309	FOB ONE STEP RAPID TEST	2011-09-14
BR	82444370257	Família LH Quantitative Test Kit (Time-Resolved FIA)	Class II
BR	82444370258	Família IL-6 Quantitative Test Kit (Time-Resolved FIA)	Class II
BR	82444370260	Família Adenovirus Antigen Fluorescence Rapid Test Cassette (Swab)	Class II