Manteia Technologies Co., Ltd.

Manufacturer and brand owner in Xiamen, Fujian, China. 3 device types, 4 products catalogued, 7 clearances.

Registry build 21.09.26

Manteia Technologies Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Accelerator, Linear, Medical, System, Planning, Radiation Therapy Treatment and 1 other device type. 4 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2020.

3device types registered with the FDA
4products catalogued under its own name
7510(k) clearances

Registration

FDA registration record for Manteia Technologies Co., Ltd.
Registered name MANTEIA TECHNOLOGIES CO.,LTD.
Status Registered
Registration expires 2026
Registration number 3016686005
FEI number 3016686005
DUNS 416535464
Establishment type Manufacturer

Chinese Registration

Chinese company register details for Manteia Technologies Co., Ltd.
Chinese legal name 福建自贸试验区厦门片区Manteia数据科技有限公司
Unified social credit code 91350200MA2YFNR75B
Source NMPA UDI database

Location

Address of Manteia Technologies Co., Ltd.
City Xiamen
Province Fujian
Address Unit 3001-3005, No.5 Huizhan North Road
Postal code 361000
Country China

What It Makes

Device types Manteia Technologies Co., Ltd. is registered to make
Device type Class Listed under the names Listed since Chinese makers
Accelerator, Linear, Medical Class 2 AccuCheck, AccuCheck Radiotherapy Plan Quality Assurance System 2023 8
Radiological Image Processing Software For Radiation Therapy Class 2 AccuContour 4, AccuContour, ARTAssistant 2020 2
System, Planning, Radiation Therapy Treatment Class 2 Mozi TPS 2023 5

Own-Brand Listings

Devices catalogued by Manteia Technologies Co., Ltd.
Product Code Catalogue numbers
AccuContour QKB 4
AccuCheck IYE 2
ARTAssistant QKB 1
Mozi TPS MUJ 1

Clearances

7 clearances name Manteia Technologies Co., Ltd. as applicant. 1 is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.

510(k) clearances naming Manteia Technologies Co., Ltd. or its listings
Clearance Decision date Product code Route Held by
K260733 2026-08-26 IYE Traditional This company
K251351 2026-01-23 QKB Traditional This company
K250780 2025-12-05 QKB Traditional This company
K250696 2025-10-24 IYE Traditional This company
K223834 2023-07-20 IYE Traditional This company
K223724 2023-07-10 MUJ Traditional This company
K221706 2023-03-09 QKB Traditional This company
K191928 2020-02-28 QKB Traditional Xiamen Manteia Technology, Ltd.

From the Company

Published by the company on its own website, not by the FDA.

Information published by Manteia Technologies Co., Ltd.
Founded 2017
Main products AccuContour, Mozi TPS, AccuLearning, QA Solution
Certifications FDA, CE, NMPA

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Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

The manufacturer named here can complete this record.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

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2,581device types they are registered for
340,248device records, each naming its maker
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