Unified Business No.

54365575

Industry

Computers, Electronics & Optical Products (2,116)

Main products

Radiation & electro-medical equipment (120)

Location

6 F.-2, NO. 3-1, YUANQU ST., NANGANG DIST., TAIPEI CITY 115603, TAIWAN (R.O.C.)↗
Taipei City (812) · Nangang Dist. (213)

Listing

Public company (unlisted) (298) 6778

Organisation type

Company Limited by Shares

Founded

2013-10-04

Paid-in capital

NT$ 278,168,000

Representative

Lien Yen

Phone

02-26557297

Website

https://www.aulisa.com.tw/

Exporter

Yes — registered with the Trade Administration

Annual revenue band

< NT$20M

North American market

FCC equipment authorization FDA 510(k) clearance FDA medical device registration

Representative tenure

In office since 2015-11 (11 yrs); last handover 2015-11

Growth & profitability

Revenue 2026-09 YoY +376.0%, year-to-date +22.8%
Gross margin -165.6%, operating margin -2539.5%, net margin -2265.4% (2026-Q2 YTD)

Certifications 11

• Medical device license (Class II) (794)Official registry Valid until 2028-10-30 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-04-03 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-05-08 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-07-16 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-03-18 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-04-08 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-07-07 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-04-26 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-12-16 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-06-01 · Taiwan Food and Drug Administration (TFDA)
• RoHS (350)Self-reported

Processes & materials 7

• Home care monitoring (1) · Extracted from websiteSelf-reported
• Telehealth patient care (1) · Extracted from websiteSelf-reported
• Medical device manufacturing (2) · Extracted from websiteSelf-reported
• Infant vital sign monitoring system (1) · Extracted from websiteSelf-reported
• Wearable wireless sensing module (1) · Extracted from websiteSelf-reported
• Pulse oximetry monitor (1) · Extracted from websiteSelf-reported
• Body temperature monitoring module (1) · Extracted from websiteSelf-reported

Patents 2

• 2024 Pulse oximeter
• 2023 Blood pressure estimation device with continuous self-calibration, blood pressure estimation method and electronic device-readable recording medium

North American market evidence 11

• FCC equipment authorization 2AI5Q 2016-07-17
• FDA 510(k) clearance K233963 2025-02-25
  Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)
• FDA 510(k) clearance K233956 2025-01-30
  Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)
• FDA 510(k) clearance K240220 2024-09-27
  Aulisa Temperature Module (TM0002)
• FDA 510(k) clearance K203208 2022-06-12
  Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System
• FDA 510(k) clearance K202497 2020-10-30
  Aulisa Multiple Patient Digital Vital Sign Monitoring System
• FDA 510(k) clearance K191207 2019-06-25
  Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System
• FDA 510(k) clearance K182822 2019-03-01
  Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring System
• FDA 510(k) clearance K183067 2019-03-01
  Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System
• FDA 510(k) clearance K162580 2017-03-03
  Guardian Angel GA1000 Digital Vital Sign Monitoring System
• FDA medical device registration 3014856521 2018-10-04 – 2025-04-11
  Oximeter; Transmitters And Receivers, Physiological Signal, Radiofrequency; System, Network And Communication, Physiological Monitors and more (6)

Public registers of the US FDA, the FCC and Health Canada, matched on the registered English name. An FDA import refusal is a negative record, but also shows goods actually shipped to the US. The FCC dataset ends in 2021.

Government programs & awards 1

• Startup Award – Senior Entrepreneurship 2018 · Ministry of Economic Affairs Small & Medium Enterprise and Startup Administration

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