E-Care Technology Co., Ltd.
立鎧科技股份有限公司
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1Plants
5Certifications
< NT$20MRevenue band (est.)
- Unified Business No.
- 70679432
- Industry
- Other Manufacturing (2,432)
- Main products
- Medical devices & supplies (878)
- Location
- 8F.-11, No. 35, Xintai Rd., Zhubei City, Hsinchu County 30252, Taiwan (R.O.C.)
Hsinchu County (1,617) · Zhubei City (468) - Listing
- Not publicly issued (84,625)
- Organisation type
- Company Limited by Shares
- Representative
- Ko Kun-yuan
- Phone
- 03-553-4996
- Website
- https://www.e-care.com.tw/about-us.html
- Exporter
- Yes — registered with the Trade Administration
- Annual revenue band
- < NT$20M estimated
- Ownership
- Group subsidiary / corporate-held · WAVEGUIDE TECHNOLOGY CO., LTD.、Shang Huei Technology Co., Ltd.
- North American market
- FDA 510(k) clearance
- Representative tenure
- In office since at least 2014 (12+ years)
- Compliance record
- FDA import refusal: 1 product(s), latest 2020-08-24
Certifications 5
- Medical device license (Class I) (1,430)Official registry Valid until 2012-09-20 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2028-01-30 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2028-01-30 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2030-09-12 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2028-01-30 · Taiwan Food and Drug Administration (TFDA)
Processes & materials 1
- Polyester (339) · PolymerSelf-reported
North American market evidence 3
- FDA 510(k) clearance K170723 2018-10-25
Swaive Thermometer SWT1A - FDA 510(k) clearance K113095 2012-03-02
E-CARE INFRARED EAR THERMOMETER - FDA import refusal 3007557677 2020-07-01 – 2020-08-24
THERMOMETER, ELECTRONIC, CLINICAL
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