EUDAMED update: Aug 11, 2026

Orantech Inc.

CN-MF-000013859

Active2,690 devices

Address: YuTang, 518132 Shenzhen
Role: Manufacturer
Date of registration: Sep 29, 2021
Country: China

Orantech Inc. is a medical device manufacturer registered in EUDAMED. The company has 2,690 devices on the EU market across 10 countries. Headquartered in Shenzhen, China. Explore the regulatory profile, devices and certificates on MD Atlas.

About Orantech Inc.

: CN-MF-000013859
Role: Manufacturer
Country: China
Organization name: Orantech Inc.
EU VAT number: 91440300349737507E
Date of registration: Sep 29, 2021

Contact details for Orantech Inc.

Phone: +86 19925480758
Email: affairs@orantech.com
Website: www.orantech.com
Address: YUTANG 401, 1ST BLD, 7TH INDUSTRIAL ZONE, YULV COMMUNITY, YUTANG STREET, GUANGMING DISTRICT 518132 SHENZHEN CHINA

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Competent authority

Name: Danish Medicines Agency, Pharmacovigilance & Medical Devices

Phone: +45 44 88 95 95
Email: dkma@dkma.dk

Officers and regulatory representatives of Orantech Inc.

WANG Frank
a) 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; (b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; (c) the post-market surveillance obligations are complied; (d) the reporting obligations are fulfilled; (e) in the case of investigational devices, the statement is issued
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Connected operators

Importers

11 EU importers place this manufacturer's devices

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
SpO2 Sensors	SpO2 Sensors	`SSD-001-S09PI`	`06941691928249`	1	On the market
SpO2 Sensors	SpO2 Sensors	`SSD-006RB-W09AN`	`06941691927839`	1	On the market
SpO2 Sensors	SpO2 Sensors	`SSD-001-W09I`	`06941691927556`	1	On the market
SpO2 Sensors	SpO2 Sensors	`SSD-007RB-W09AN`	`06941691927846`	1	On the market
Bandage	Bandage	`M07-B001-08`	`06941691977223`	1	On the market
Bandage	Bandage	`M07-B006-08`	`06941691977278`	1	On the market
Bandage	Bandage	`M07-B006`	`06941691977261`	1	On the market
Bandage	Bandage	`M07-B002`	`06941691977209`	1	On the market
Bandage	Bandage	`M07-B004`	`06941691977247`	1	On the market
Bandage	Bandage	`M07-B003`	`06941691977230`	1	On the market
Bandage	Bandage	`M07-B002-08`	`06941691977216`	1	On the market
Bandage	Bandage	`M07-B001`	`06941691977193`	1	On the market
Bandage	Bandage	`M07-B003-08`	`06941691977254`	1	On the market
C900301	C900301	`SS-183-AF30`	`06941691985884`	1	On the market
Cardiac output cables	Cardiac output cables	`COCA-EW02-01`	`06941691985990`	1	On the market
Cardiac output cables	Cardiac output cables	`COCA-MR01-01`	`06941691982821`	1	On the market
Cardiac output cables	Cardiac output cables	`COCA-MQ-36`	`06941691973683`	1	On the market
Cardiac output cables	Cardiac output cables	`COCB-DG01-25`	`06941691971061`	1	On the market
Cardiac output cables	Cardiac output cables	`COCA-BLT01-01`	`06941691982883`	1	On the market
Cardiac output cables	Cardiac output cables	`COCA-EW03-01`	`06941691986003`	1	On the market
Cardiac output cables	Cardiac output cables	`COCA-PH01-01`	`06941691982869`	1	On the market
Cardiac output cables	Cardiac output cables	`COCB-PH-48`	`06941691969976`	1	On the market
Cardiac output cables	Cardiac output cables	`COCA-MR02-01`	`06941691982838`	1	On the market
Cardiac output cables	Cardiac output cables	`COCA-SL01-01`	`06941691982876`	1	On the market
Cardiac output cables	Cardiac output cables	`COCA-PH-27`	`06941691980520`	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
SpO2 Sensors	SpO2 Sensors	`SSD-001-S09PI`	`06941691928249`	1	On the market
SpO2 Sensors	SpO2 Sensors	`SSD-006RB-W09AN`	`06941691927839`	1	On the market
SpO2 Sensors	SpO2 Sensors	`SSD-001-W09I`	`06941691927556`	1	On the market
SpO2 Sensors	SpO2 Sensors	`SSD-007RB-W09AN`	`06941691927846`	1	On the market
Bandage	Bandage	`M07-B001-08`	`06941691977223`	1	On the market
Bandage	Bandage	`M07-B006-08`	`06941691977278`	1	On the market
Bandage	Bandage	`M07-B006`	`06941691977261`	1	On the market
Bandage	Bandage	`M07-B002`	`06941691977209`	1	On the market
Bandage	Bandage	`M07-B004`	`06941691977247`	1	On the market
Bandage	Bandage	`M07-B003`	`06941691977230`	1	On the market
Bandage	Bandage	`M07-B002-08`	`06941691977216`	1	On the market
Bandage	Bandage	`M07-B001`	`06941691977193`	1	On the market
Bandage	Bandage	`M07-B003-08`	`06941691977254`	1	On the market
C900301	C900301	`SS-183-AF30`	`06941691985884`	1	On the market
Cardiac output cables	Cardiac output cables	`COCA-EW02-01`	`06941691985990`	1	On the market
Cardiac output cables	Cardiac output cables	`COCA-MR01-01`	`06941691982821`	1	On the market
Cardiac output cables	Cardiac output cables	`COCA-MQ-36`	`06941691973683`	1	On the market
Cardiac output cables	Cardiac output cables	`COCB-DG01-25`	`06941691971061`	1	On the market
Cardiac output cables	Cardiac output cables	`COCA-BLT01-01`	`06941691982883`	1	On the market
Cardiac output cables	Cardiac output cables	`COCA-EW03-01`	`06941691986003`	1	On the market
Cardiac output cables	Cardiac output cables	`COCA-PH01-01`	`06941691982869`	1	On the market
Cardiac output cables	Cardiac output cables	`COCB-PH-48`	`06941691969976`	1	On the market
Cardiac output cables	Cardiac output cables	`COCA-MR02-01`	`06941691982838`	1	On the market
Cardiac output cables	Cardiac output cables	`COCA-SL01-01`	`06941691982876`	1	On the market
Cardiac output cables	Cardiac output cables	`COCA-PH-27`	`06941691980520`	1	On the market

Orantech Inc.

About Orantech Inc.

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About Orantech Inc.

Contact details for Orantech Inc.

Export the 2,690 devices of Orantech Inc.

Competent authority

Officers and regulatory representatives of Orantech Inc.

Statistics for Orantech Inc.

Certificate health for Orantech Inc.

Devices by risk class

Market presence of Orantech Inc.

Device catalog for Orantech Inc.

Device families (Basic UDI-DI) of Orantech Inc.

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Importers

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Certificate health for Orantech Inc.

Statistics for Orantech Inc.

Market presence of Orantech Inc.

Devices by risk class

Device catalog for Orantech Inc.

Device families (Basic UDI-DI) of Orantech Inc.