EUDAMED update: Apr 15, 2026

Zhejiang Orient Gene Biotech Co., Ltd

CN-MF-000017965

Active618 devices

Address: East Yangguang Avenue, Dipu Street, Anji 313300, 3787# 313300 Huzhou, Zhejiang
Role: Manufacturer
Date of registration: Dec 13, 2021
Country: China

Zhejiang Orient Gene Biotech Co., Ltd is a medical device manufacturer registered in EUDAMED. The company has 618 devices on the EU market across 12 countries. It holds 17 valid CE certificates. Headquartered in Huzhou,Zhejiang, China. Explore the regulatory profile, devices and certificates on MD Atlas.

About Orient Gene Biotech

: CN-MF-000017965
Role: Manufacturer
Country: China
Organization name: Zhejiang Orient Gene Biotech Co., Ltd
EU VAT number: Not applicable
Trade register: 913305007804719612
Date of registration: Dec 13, 2021

Contact details for Orient Gene Biotech

Email: joyce.pang@orientgene.com
Address: 3787#, EAST YANGGUANG AVENUE, DIPU STREET, ANJI 313300 313300 HUZHOU,ZHEJIANG CHINA

Competent authority

Name: Agencia Española de Medicamentos y Productos Sanitarios

Phone: +34 (91) 822 5274
Email: sgps@aemps.es

Officers and regulatory representatives of Orient Gene Biotech

MIAO July
the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released, Sign batch product release approval.
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YANG Young
1. the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date. 2. For devices conducting clinical trials, the statement referred to in Section 4.1 of Annex XIV is issued. That is, "in addition to the aspects covered in clinical trials, the device meets general safety and performance requirements and precautions have been taken to protect the health and safety of users".
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PANG Joyce
1) comply with the marketing surveillance obligation under Article 10(9) to make sure that the device manufacturer shall implement and maintain an up-to-date PMS system in accordance with Article 78, sign and approve the PMS plan, the PMS report and the PSUR.2) fulfillment of reporting obligations under Articles 82 to 86 of the vigilance system, including reporting and analysis of serious accidents and FSCA, trend reporting and implementing acts. 3)sign the EU DOC and keep it up-to-date.
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Importers

10 EU importers place this manufacturer's devices

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Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
25-OH-VD Quantitative Test Kit (Time-Resolved FIA)	25-OH-VD Quantitative Test Kit (Time-Resolved FIA)	`FIVD-402a-DR10`	`06950996003902`	10	On the market
25-OH-VD Control	25-OH-VD Control	`FIVD-PN20`	`D-FIVD-PN20E5`	1	On the market
25-OH-VD Quantitative Test Kit (Time-Resolved FIA)	25-OH-VD Quantitative Test Kit (Time-Resolved FIA)	`FIVD-402a-DRHG`	`06950996096065`	25	On the market
25-OH-VD Quantitative Test Kit (Time-Resolved FIA)	25-OH-VD Quantitative Test Kit (Time-Resolved FIA)	`FIVD-402a-DR`	`06950996003919`	25	On the market
Adenovirus Antigen Control Kit	Adenovirus Antigen Control Kit	`GCADE-PN2`	`D-GCADE-PN23K`	1	On the market
Adenovirus Antigen FIA Control Kit	Adenovirus Antigen FIA Control Kit	`FCADE-PN2`	`D-FCADE-PN22U`	1	On the market
Adenovirus Antigen Fluorescence Rapid Test Cassette (Swab)	Adenovirus Antigen Fluorescence Rapid Test Cassette (Swab)	`FCADE-502Ca`	`D-FCADE-502CaEN`	1	On the market
Adenovirus Antigen Fluorescence Rapid Test Cassette (Swab)	Adenovirus Antigen Fluorescence Rapid Test Cassette (Swab)	`FCADE-502a`	`D-FCADE-502aMC`	1	On the market
Adenovirus Rapid Test Cassette (Feces)	Adenovirus Rapid Test Cassette (Feces)	`GCADE-602a`	`D-GCADE-602aNG`	1	On the market
AFP Control	AFP Control	`FEAFP-PN20`	`D-FEAFP-PN203X`	1	On the market
AFP Quantitative Test Kit (Time-Resolved FIA)	AFP Quantitative Test Kit (Time-Resolved FIA)	`FEAFP-302a`	`D-FEAFP-302aTV`	1	On the market
Alpha-Fetoprotein Rapid Test Cassette(Whole Blood/Serum/Plasma)	Alpha-Fetoprotein Rapid Test Cassette(Whole Blood/Serum/Plasma)	`GEAFP-402a`	`D-GEAFP-402aUZ`	1	On the market
Alpha-Fetoprotein Rapid Test Strip (Whole Blood/Serum/Plasma)	Alpha-Fetoprotein Rapid Test Strip (Whole Blood/Serum/Plasma)	`GEAFP-401a`	`D-GEAFP-401aUW`	1	On the market
AMH Control	AMH Control	`FAAMH-PN20`	`D-FAAMH-PN20ZF`	1	On the market
AMH Quantitative Test Kit (Time-Resolved FIA)	AMH Quantitative Test Kit (Time-Resolved FIA)	`FAAMH-302a`	`D-FAAMH-302aRG`	1	On the market
AMH Quantitative Test Kit (Time-Resolved FIA)	AMH Quantitative Test Kit (Time-Resolved FIA)	`FAAMH-402a`	`D-FAAMH-402aRP`	1	On the market
Analysis Kit for Fifteen Autoantibodies Spectrum (Flowcytometry Fluorescence Method)	Analysis Kit for Fifteen Autoantibodies Spectrum (Flowcytometry Fluorescence Method)	`1AA15B11`	`06950996004442`	1	On the market
Anti-Tissue-Transglutaminase IgA Rapid Test Cassette (Whole Blood)	Anti-Tissue-Transglutaminase IgA Rapid Test Cassette (Whole Blood)	`GGTTG-402a`	`D-GGTTG-402aOGJP`	1	On the market
Beta-HCG Control	Beta-HCG Control	`FAHCG-PN20`	`D-FAHCG-PN20XV`	1	On the market
Beta2-MG Control	Beta2-MG Control	`FIMG-PN20`	`D-FIMG-PN20AK`	1	On the market
Bladder Tumor Antigen Rapid Test Cassette (Urine)	Bladder Tumor Antigen Rapid Test Cassette (Urine)	`GEBTA-102a`	`D-GEBTA-102aWA`	1	On the market
BNP Control	BNP Control	`FDBNA-PN20`	`D-FDBNA-PN20ZV`	1	On the market
BNP Quantitative Test Kit (Time-Resolved FIA)	BNP Quantitative Test Kit (Time-Resolved FIA)	`FDBNA-402a`	`D-FDBNA-402aS5`	1	On the market
Bordetella Pertussis Antigen Rapid Test Kit (Colloidal Gold)	Bordetella Pertussis Antigen Rapid Test Kit (Colloidal Gold)	`GCBP-502a`	`D-GCBP-502aOGKF`	1	On the market
Brucella Antibody Rapid Test Cassette (Whole Blood/Serum/Plasma)	Brucella Antibody Rapid Test Cassette (Whole Blood/Serum/Plasma)	`GCBRU-402a`	`D-GCBRU-402a4N`	1	On the market

Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
25-OH-VD Quantitative Test Kit (Time-Resolved FIA)	25-OH-VD Quantitative Test Kit (Time-Resolved FIA)	`FIVD-402a-DR10`	`06950996003902`	10	On the market
25-OH-VD Control	25-OH-VD Control	`FIVD-PN20`	`D-FIVD-PN20E5`	1	On the market
25-OH-VD Quantitative Test Kit (Time-Resolved FIA)	25-OH-VD Quantitative Test Kit (Time-Resolved FIA)	`FIVD-402a-DRHG`	`06950996096065`	25	On the market
25-OH-VD Quantitative Test Kit (Time-Resolved FIA)	25-OH-VD Quantitative Test Kit (Time-Resolved FIA)	`FIVD-402a-DR`	`06950996003919`	25	On the market
Adenovirus Antigen Control Kit	Adenovirus Antigen Control Kit	`GCADE-PN2`	`D-GCADE-PN23K`	1	On the market
Adenovirus Antigen FIA Control Kit	Adenovirus Antigen FIA Control Kit	`FCADE-PN2`	`D-FCADE-PN22U`	1	On the market
Adenovirus Antigen Fluorescence Rapid Test Cassette (Swab)	Adenovirus Antigen Fluorescence Rapid Test Cassette (Swab)	`FCADE-502Ca`	`D-FCADE-502CaEN`	1	On the market
Adenovirus Antigen Fluorescence Rapid Test Cassette (Swab)	Adenovirus Antigen Fluorescence Rapid Test Cassette (Swab)	`FCADE-502a`	`D-FCADE-502aMC`	1	On the market
Adenovirus Rapid Test Cassette (Feces)	Adenovirus Rapid Test Cassette (Feces)	`GCADE-602a`	`D-GCADE-602aNG`	1	On the market
AFP Control	AFP Control	`FEAFP-PN20`	`D-FEAFP-PN203X`	1	On the market
AFP Quantitative Test Kit (Time-Resolved FIA)	AFP Quantitative Test Kit (Time-Resolved FIA)	`FEAFP-302a`	`D-FEAFP-302aTV`	1	On the market
Alpha-Fetoprotein Rapid Test Cassette(Whole Blood/Serum/Plasma)	Alpha-Fetoprotein Rapid Test Cassette(Whole Blood/Serum/Plasma)	`GEAFP-402a`	`D-GEAFP-402aUZ`	1	On the market
Alpha-Fetoprotein Rapid Test Strip (Whole Blood/Serum/Plasma)	Alpha-Fetoprotein Rapid Test Strip (Whole Blood/Serum/Plasma)	`GEAFP-401a`	`D-GEAFP-401aUW`	1	On the market
AMH Control	AMH Control	`FAAMH-PN20`	`D-FAAMH-PN20ZF`	1	On the market
AMH Quantitative Test Kit (Time-Resolved FIA)	AMH Quantitative Test Kit (Time-Resolved FIA)	`FAAMH-302a`	`D-FAAMH-302aRG`	1	On the market
AMH Quantitative Test Kit (Time-Resolved FIA)	AMH Quantitative Test Kit (Time-Resolved FIA)	`FAAMH-402a`	`D-FAAMH-402aRP`	1	On the market
Analysis Kit for Fifteen Autoantibodies Spectrum (Flowcytometry Fluorescence Method)	Analysis Kit for Fifteen Autoantibodies Spectrum (Flowcytometry Fluorescence Method)	`1AA15B11`	`06950996004442`	1	On the market
Anti-Tissue-Transglutaminase IgA Rapid Test Cassette (Whole Blood)	Anti-Tissue-Transglutaminase IgA Rapid Test Cassette (Whole Blood)	`GGTTG-402a`	`D-GGTTG-402aOGJP`	1	On the market
Beta-HCG Control	Beta-HCG Control	`FAHCG-PN20`	`D-FAHCG-PN20XV`	1	On the market
Beta2-MG Control	Beta2-MG Control	`FIMG-PN20`	`D-FIMG-PN20AK`	1	On the market
Bladder Tumor Antigen Rapid Test Cassette (Urine)	Bladder Tumor Antigen Rapid Test Cassette (Urine)	`GEBTA-102a`	`D-GEBTA-102aWA`	1	On the market
BNP Control	BNP Control	`FDBNA-PN20`	`D-FDBNA-PN20ZV`	1	On the market
BNP Quantitative Test Kit (Time-Resolved FIA)	BNP Quantitative Test Kit (Time-Resolved FIA)	`FDBNA-402a`	`D-FDBNA-402aS5`	1	On the market
Bordetella Pertussis Antigen Rapid Test Kit (Colloidal Gold)	Bordetella Pertussis Antigen Rapid Test Kit (Colloidal Gold)	`GCBP-502a`	`D-GCBP-502aOGKF`	1	On the market
Brucella Antibody Rapid Test Cassette (Whole Blood/Serum/Plasma)	Brucella Antibody Rapid Test Cassette (Whole Blood/Serum/Plasma)	`GCBRU-402a`	`D-GCBRU-402a4N`	1	On the market

Zhejiang Orient Gene Biotech Co., Ltd

About Orient Gene Biotech

Contact details for Orient Gene Biotech

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Officers and regulatory representatives of Orient Gene Biotech

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Device catalog for Orient Gene Biotech

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Connected operators

Importers

Export the 618 devices of Orient Gene Biotech

Related searches

Certificate health for Orient Gene Biotech

Statistics for Orient Gene Biotech

Market presence of Orient Gene Biotech

Devices by risk class

Related documents

Device catalog for Orient Gene Biotech

Device families (Basic UDI-DI) of Orient Gene Biotech