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EVER FORTUNE.AI CO., LTD.

長佳智能股份有限公司

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2018Founded

NT$952MPaid-in capital

0Plants

22Certifications

14Patents

NT$100–500MRevenue band

Unified Business No.: 50824681
Industry: Tobacco Manufacturing (1,186)
Listing: Listed (TPEx) (890) 6841
Founded: 2018-06-28
Paid-in capital: NT$ 952,230,000
Phone: 04-2321-3838
Website: https://www.everfortuneai.com.tw/
Exporter: Yes — registered with the Trade Administration
Annual revenue band: NT$100–500M
Ownership: Group subsidiary / corporate-held · CENTER LABORATORIES INC.、QUANTA COMPUTER INC.、Kuang Ta Computer Co., Ltd.、Ta Yin Tou Tzu Co., Ltd.、Chu Shih Technology Co., Ltd.
North American market: FDA 510(k) clearance FDA medical device registration
Representative tenure: In office since 2020-01 (6 yrs); last handover 2020-01
Growth & profitability: Revenue 2026-09 YoY +65.3%, year-to-date +18.2%
Gross margin 73.1%, operating margin 14.6%, net margin 5.5% (2026-Q2 YTD)

Certifications 22

Medical device license (Class I) (1,430)Official registry Valid until 2031-01-28 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2028-11-27 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2031-07-26 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2027-11-28 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2027-11-07 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2027-04-11 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2027-04-12 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2027-05-30 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2026-11-09 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-12-15 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2026-12-17 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-06-18 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-08-13 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-03-16 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2031-07-23 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-04-13 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-12-12 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-12-15 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-04-16 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-10-09 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-10-12 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2026-07-26 · Taiwan Food and Drug Administration (TFDA)

Patents 14

2026 Image processing system for organ outlining
2026 Emergency clinical decision support system
2025 Prognostic risk analysis system for head and neck cancer

North American market evidence 16

FDA 510(k) clearance K253163 2026-04-22
EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)
FDA 510(k) clearance K251306 2026-01-28
Seg Pro V3 (RT-300)
FDA 510(k) clearance K242821 2025-02-20
EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)
FDA 510(k) clearance K241923 2024-12-06
EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100)
FDA 510(k) clearance K234042 2024-06-07
EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)
FDA 510(k) clearance K240291 2024-04-08
EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM
FDA 510(k) clearance K231025 2023-10-04
EFAI NeuroSuite CT ICH Assessment System
FDA 510(k) clearance K231928 2023-09-25
EFAI RTSUITE CT HCAP-Segmentation System
FDA 510(k) clearance K232100 2023-08-08
Efai Pacs Picture Archiving and Communication System Pro
FDA 510(k) clearance K221552 2022-11-08
EFAI ChestSuite XR Pneumothorax Assessment System
FDA 510(k) clearance K222076 2022-09-08
EFAI ChestSuite XR Pleural Effusion Assessment System
FDA 510(k) clearance K213731 2022-05-31
EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows
FDA 510(k) clearance K220264 2022-04-28
EFAI RTSuite CT HN-Segmentation System
FDA 510(k) clearance K212624 2022-04-04
EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System
FDA 510(k) clearance K211257 2021-09-10
EFAI PACS Picture Archiving and Communication System
FDA medical device registration 3021032044 2021-10-24 – 2026-02-05
Radiological Computer-Assisted Triage And Notification Software; Radiological Image Processing Software For Radiation Therapy; System, Image Processing, Radiological and more (6)

Recent changes 3

2026-12-17
Certification expiry · UpcomingMedical device license (Class II) certificate expires on 2026-12-17
2026-11-09
Certification expiry · UpcomingMedical device license (Class II) certificate expires on 2026-11-09
2026-07-26
Certification expiryMedical device license (Class II) certificate expired on 2026-07-26

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