GOLDEN SMART HOME TECHNOLOGY CORP.

Unified Business No.

53786079

Industry

Other Manufacturing (2,432)

Main products

Medical devices & supplies (878)

Location

RM. 206, NO. 47, YUANQU 2ND RD., EAST DIST., HSINCHU CITY 300, TAIWAN (R.O.C.)↗
Hsinchu City (1,019) · East Dist. (401)

Listing

Not publicly issued (84,625)

Registration status

Approved / Active

Organisation type

Company Limited by Shares

Founded

2012-01-03

Paid-in capital

NT$ 618,259,290

Representative

Chou Ching-lieng

Phone

03-5770693

Website

https://www.goldensmarthome.com.tw/zh-tw

Exporter

Yes — registered with the Trade Administration

Annual revenue band

NT$100–500M estimated

Ownership

Individually held

North American market

FCC equipment authorization FDA medical device registration

Representative tenure

In office since 2020-08 (6 yrs); last handover 2020-08

Compliance record

FDA import refusal: 3 product(s), latest 2024-03-19
Labour Standards Act penalties: 2 case(s) in 5 years, latest 2024-08-26, fines NT$ 70,000 (Art. 24; Art. 22) — matched by company name

Plants 3

• Plant · 206 Shi, No. 47, Yuanqu 2nd Rd. (Hsinchu Science Park), East Dist., Hsinchu City↗ In production
• Plant 3 · 2F, No. 12, Yanfa 2nd Rd. (Hsinchu Science Park), East Dist., Hsinchu City↗ In production
• Plant 2 · 2F, No. 15, Yanfa 2nd Rd. (Hsinchu Science Park), East Dist., Hsinchu City↗ In production

Certifications 24

• Medical device license (Class I) (1,430)Official registry Valid until 2026-10-31 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2023-02-01 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-06-05 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-08-22 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-06-13 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-07-30 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2023-02-08 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2026-02-01 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2021-10-07 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2026-04-27 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-05-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2020-05-18 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2025-06-05 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2025-06-16 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-04-01 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-11-06 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-11-16 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-05-31 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2026-05-31 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-02-07 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-08-10 · Taiwan Food and Drug Administration (TFDA)
• FDA (53)Self-reported
• GMP (261)Self-reported
• ISO 13485 (310)Self-reported

Patents 12

• 2026 Remote electrical stimulation system
• 2026 AI-assisted group cognitive training fitness system
• 2025 Remote electrical stimulation system

North American market evidence 3

• FCC equipment authorization 2AT6S 2019-07-30
• FDA medical device registration 3015188281 2019-07-02 – 2023-03-26
  Continuous Measurement Thermometer; Single (Specified) Analyte Controls (Assayed And Unassayed); System, Test, Blood Glucose, Over The Counter and more (7)
• FDA import refusal 3015188281 2024-03-19
  THERMOMETER, ELECTRONIC, CLINICAL; SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER; SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Recent changes 4

• 2026-10-31
  Certification expiryMedical device license (Class I) certificate expired on 2026-10-31
• 2026-05-31
  Certification expiryMedical device license (Class II) certificate expired on 2026-05-31
• 2026-04-27
  Certification expiryMedical device license (Class II) certificate expired on 2026-04-27
• 2026-02-01
  Certification expiryMedical device license (Class II) certificate expired on 2026-02-01

RSS feed · Recent changes at Taiwanese manufacturers →

Similar companies 10

• HMD BIOMEDICAL INC. · Hsinchu County Public company (unlisted) NT$100–500M
  Shared: Medical device license (Class I), Medical device license (Class II), FDA, GMP
• IXENSOR CO., LTD. · Taipei City Emerging stock (TPEx) NT$20–100M
  Shared: Medical device license (Class I), Medical device license (Class II), FDA, GMP
• PEGAVISION CORPORATION · Taoyuan City Listed (TWSE) ≥ NT$5B
  Shared: Medical device license (Class I), Medical device license (Class II), GMP, ISO 13485
• ROLENCE ENTERPRISE INC. · Taoyuan City NT$20–100M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), GMP, ISO 13485
• MARIA VON MED-BIOTECHNOLOGY CO., LTD. · New Taipei City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), GMP, ISO 13485
• CARILEX MEDICAL, INC. · Taoyuan City Emerging stock (TPEx) NT$100–500M
  Shared: Medical device license (Class I), Medical device license (Class II), FDA, ISO 13485
• Faciox Inc. · New Taipei City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c., Medical equipment wholesale
• NANOSIGMA BIOTECH. CO., LTD. · New Taipei City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c., Medical equipment wholesale
• BIO CONCEPT INC. · Taichung City NT$20–100M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c., Medical equipment wholesale
• CHANPIN MEDTAK CO., LTD. · New Taipei City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c., Medical equipment wholesale

Open in advanced filters →