EUDAMED update: Mar 24, 2026

Sichuan Orienter Biotechnology Co., Ltd.

CN-MF-000003026

Active111 devices

Address: No.9, Kangqiang 4th Road, Hi-tech Zone Chengdu, 611731 Chengdu
Role: Manufacturer
Date of registration: Apr 15, 2021
Country: China

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Sichuan Orienter Biotechnology Co., Ltd. is a medical device manufacturer registered in EUDAMED. The company has 111 devices on the EU market across 4 countries. Headquartered in Chengdu, China. Explore the regulatory profile, devices and certificates on MD Atlas.

Role
Country
Date of registration
Address

EUDAMED update: Mar 24, 2026

Sichuan Orienter Biotechnology Co., Ltd.

CN-MF-000003026

Active111 devices

Address: No.9, Kangqiang 4th Road, Hi-tech Zone Chengdu, 611731 Chengdu
Role: Manufacturer
Date of registration: Apr 15, 2021
Country: China

Is this your company? Claim it to add your logo, story and links — free.Claim this page

About Sichuan Orienter Biotechnology Co., Ltd.

SRN: CN-MF-000003026
Role: Manufacturer
Country: China
Organization name: Sichuan Orienter Biotechnology Co., Ltd.
EU VAT number: 91510100577371682N
Date of registration: Apr 15, 2021

Contact details for Sichuan Orienter Biotechnology Co., Ltd.

Phone: +86-28-62533858
Email: info@orienterglobal.com
Website: www.orienterglobal.com
Address: NO.9, KANGQIANG 4TH ROAD, HI-TECH ZONE CHENGDU 611731 CHENGDU CHINA

Competent authority

Name: Ministerie van Volksgezondheid, Welzijn en Sport
SRN: NL-CA-058
Phone: +31 70 340 79 11
Email: medische_hulpmiddelen@minvws.nl

Officers and regulatory representatives of Sichuan Orienter Biotechnology Co., Ltd.

YANG Longxian
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Certificate health for Sichuan Orienter Biotechnology Co., Ltd.

No certificates registered for this manufacturer.

Trade name	Reference / catalog number	UDI-DI code	Quantity	Status
Carbohydrate Antigen 125 (CA125) Assay Kit (Chemiluminescent Immunoassay)	`DD0901`	`06970522642788`	1	On the market
Carbohydrate Antigen 19-9 (CA19-9) Assay Kit (Chemiluminescent Immunoassay)	`DD1101`	`06970522645505`	1	On the market
2×50 test/box Calibrator:0.5mL×2	`CL1703`	`06970522641651`	1	On the market
25-Hydroxy Vitamin D (25-OH VD) Assay Kit (Chemiluminescent Immunoassay)	`CJ0102A`	`06970522649176`	1	On the market
3,5,3´-Triiodothyronine (T3) Assay Kit (Chemiluminescent Immunoassay)	`CL0302`	`06970522648872`	1	On the market
Alpha Fetoprotein (AFP) Assay Kit (Chemiluminescent Immunoassay)	`DD0101`	`06970522641057`	1	On the market
Alpha Tumor Necrosis Factor (TNFα) Assay Kit (Chemiluminescent Immunoassay)	`DC0601`	`06970522642290`	1	On the market
Anti-beta 2 Glycoprotein 1 Antibody IgA/G/M (β2-GP1-IgA/G/M) Assay Kit (Chemiluminescent Immunoassay)	`DB2001`	`06942028502200`	1	On the market
Anti-cardiolipin antibody IgA/G/M (aCL-A/G/M) Assay Kit (Chemiluminescent Immunoassay)	`DB1601`	`06942028502040`	1	On the market
Anti-cyclic Citrullinated Peptide Antibody (Anti-CCP) Assay Kit (Chemiluminescent Immunoassay)	`DB0301`	`06970522641101`	1	On the market
Anti-endometrial antibody IgG (EM-IgG) Dectection Kit (Chemiluminescent Immunoassay)	`DB1001`	`06970522647790`	1	On the market
Anti-endometrial antibody IgM (EM-IgM) Dectection Kit (Chemiluminescent Immunoassay)	`DB1101`	`06970522647936`	1	On the market
Anti-Human Chorionic Gonadotropin antibody (HCG-Ab) Detection Kit (Chemiluminescent Immunoassay)	`DB1401`	`06942028501968`	1	On the market
Anti-Mullerian Hormone (AMH) Assay Kit (Chemiluminescent Immunoassay)	`CL1402`	`06970522649589`	1	On the market
Anti-ovarian antibody IgG (AOA-IgG) Dectection Kit (Chemiluminescent Immunoassay)	`DB0601`	`06970522640975`	1	On the market
Anti-ovarian antibody IgM (AOA-IgM) Dectection Kit (Chemiluminescent Immunoassay)	`DB0701`	`06970522640692`	1	On the market
Anti-sperm antibody IgG (ASA-IgG) Dectection Kit (Chemiluminescent Immunoassay)	`DB0401`	`06970522640791`	1	On the market
Anti-sperm antibody IgM (ASA-IgM) Dectection Kit (Chemiluminescent Immunoassay)	`DB0501`	`06970522640913`	1	On the market
Anti-Thyroglobulin Antibody (Anti-TG) Assay Kit (Chemiluminescent Immunoassay)	`CL0602`	`06970522649237`	1	On the market
Anti-Thyroid Peroxidase Antibody (Anti-TPO) Assay Kit (Chemiluminescent Immunoassay)	`CL0702`	`06970522649251`	1	On the market
Anti-trophoblast cell membrane antibody(TA-Ab) Detection Kit (Chemiluminescent Immunoassay)	`DB2201`	`06942028502569`	1	On the market
Anti-zona pellucida antibody IgG(ZP-IgG) Detection Kit (Chemiluminescent Immunoassay)	`DB1201`	`06942028501883`	1	On the market
Anti-zona pellucida antibody IgM(ZP-IgM) Detection Kit (Chemiluminescent Immunoassay)	`DB1301`	`06942028501920`	1	On the market
Automatic Chemiluminescence Immunoassay Analyzer	`QD0301`	`06970522640043`	1	On the market
Automatic Chemiluminescence Immunoassay Analyzer	`QD0201`	`06970522640036`	1	On the market

Trade name	Reference / catalog number	UDI-DI code	Quantity	Status
Carbohydrate Antigen 125 (CA125) Assay Kit (Chemiluminescent Immunoassay)	`DD0901`	`06970522642788`	1	On the market
Carbohydrate Antigen 19-9 (CA19-9) Assay Kit (Chemiluminescent Immunoassay)	`DD1101`	`06970522645505`	1	On the market
2×50 test/box Calibrator:0.5mL×2	`CL1703`	`06970522641651`	1	On the market
25-Hydroxy Vitamin D (25-OH VD) Assay Kit (Chemiluminescent Immunoassay)	`CJ0102A`	`06970522649176`	1	On the market
3,5,3´-Triiodothyronine (T3) Assay Kit (Chemiluminescent Immunoassay)	`CL0302`	`06970522648872`	1	On the market
Alpha Fetoprotein (AFP) Assay Kit (Chemiluminescent Immunoassay)	`DD0101`	`06970522641057`	1	On the market
Alpha Tumor Necrosis Factor (TNFα) Assay Kit (Chemiluminescent Immunoassay)	`DC0601`	`06970522642290`	1	On the market
Anti-beta 2 Glycoprotein 1 Antibody IgA/G/M (β2-GP1-IgA/G/M) Assay Kit (Chemiluminescent Immunoassay)	`DB2001`	`06942028502200`	1	On the market
Anti-cardiolipin antibody IgA/G/M (aCL-A/G/M) Assay Kit (Chemiluminescent Immunoassay)	`DB1601`	`06942028502040`	1	On the market
Anti-cyclic Citrullinated Peptide Antibody (Anti-CCP) Assay Kit (Chemiluminescent Immunoassay)	`DB0301`	`06970522641101`	1	On the market
Anti-endometrial antibody IgG (EM-IgG) Dectection Kit (Chemiluminescent Immunoassay)	`DB1001`	`06970522647790`	1	On the market
Anti-endometrial antibody IgM (EM-IgM) Dectection Kit (Chemiluminescent Immunoassay)	`DB1101`	`06970522647936`	1	On the market
Anti-Human Chorionic Gonadotropin antibody (HCG-Ab) Detection Kit (Chemiluminescent Immunoassay)	`DB1401`	`06942028501968`	1	On the market
Anti-Mullerian Hormone (AMH) Assay Kit (Chemiluminescent Immunoassay)	`CL1402`	`06970522649589`	1	On the market
Anti-ovarian antibody IgG (AOA-IgG) Dectection Kit (Chemiluminescent Immunoassay)	`DB0601`	`06970522640975`	1	On the market
Anti-ovarian antibody IgM (AOA-IgM) Dectection Kit (Chemiluminescent Immunoassay)	`DB0701`	`06970522640692`	1	On the market
Anti-sperm antibody IgG (ASA-IgG) Dectection Kit (Chemiluminescent Immunoassay)	`DB0401`	`06970522640791`	1	On the market
Anti-sperm antibody IgM (ASA-IgM) Dectection Kit (Chemiluminescent Immunoassay)	`DB0501`	`06970522640913`	1	On the market
Anti-Thyroglobulin Antibody (Anti-TG) Assay Kit (Chemiluminescent Immunoassay)	`CL0602`	`06970522649237`	1	On the market
Anti-Thyroid Peroxidase Antibody (Anti-TPO) Assay Kit (Chemiluminescent Immunoassay)	`CL0702`	`06970522649251`	1	On the market
Anti-trophoblast cell membrane antibody(TA-Ab) Detection Kit (Chemiluminescent Immunoassay)	`DB2201`	`06942028502569`	1	On the market
Anti-zona pellucida antibody IgG(ZP-IgG) Detection Kit (Chemiluminescent Immunoassay)	`DB1201`	`06942028501883`	1	On the market
Anti-zona pellucida antibody IgM(ZP-IgM) Detection Kit (Chemiluminescent Immunoassay)	`DB1301`	`06942028501920`	1	On the market
Automatic Chemiluminescence Immunoassay Analyzer	`QD0301`	`06970522640043`	1	On the market
Automatic Chemiluminescence Immunoassay Analyzer	`QD0201`	`06970522640036`	1	On the market

Sichuan Orienter Biotechnology Co., Ltd.

Sichuan Orienter Biotechnology Co., Ltd.

About Sichuan Orienter Biotechnology Co., Ltd.

Contact details for Sichuan Orienter Biotechnology Co., Ltd.

Competent authority

Officers and regulatory representatives of Sichuan Orienter Biotechnology Co., Ltd.

Certificate health for Sichuan Orienter Biotechnology Co., Ltd.

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About Sichuan Orienter Biotechnology Co., Ltd.

Contact details for Sichuan Orienter Biotechnology Co., Ltd.

Competent authority

Officers and regulatory representatives of Sichuan Orienter Biotechnology Co., Ltd.

Statistics for Sichuan Orienter Biotechnology Co., Ltd.

Certificate health for Sichuan Orienter Biotechnology Co., Ltd.

Related documents

Devices by risk class

Device catalog for Sichuan Orienter Biotechnology Co., Ltd.

Device families (Basic UDI-DI) of Sichuan Orienter Biotechnology Co., Ltd.

Market presence of Sichuan Orienter Biotechnology Co., Ltd.

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Statistics for Sichuan Orienter Biotechnology Co., Ltd.

Device catalog for Sichuan Orienter Biotechnology Co., Ltd.

Device families (Basic UDI-DI) of Sichuan Orienter Biotechnology Co., Ltd.

Market presence of Sichuan Orienter Biotechnology Co., Ltd.