SIGKNOW BIOMEDICAL CO., LTD.
準訊生醫股份有限公司
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1Plants
14Certifications
7Patents
< NT$20MRevenue band (est.)
- Unified Business No.
- 54621478
- Industry
- Computers, Electronics & Optical Products (2,145)
- Main products
- Radiation & electro-medical equipment (120)
- Location
- 10 F.-2, No. 760, Sec. 4, Bade Rd., Songshan Dist., Taipei City 105412, Taiwan (R.O.C.)
New Taipei City (16,829) · Xizhi Dist. (1,300) - Listing
- Not publicly issued (84,625)
- Organisation type
- Company Limited by Shares
- Representative
- Wu Chih-lieng
- Phone
- 02-27612577
- Website
- https://www.sigknow.com/
- Exporter
- Yes — registered with the Trade Administration
- Annual revenue band
- < NT$20M estimated
- Ownership
- Group subsidiary / corporate-held · SIGKNOWCO.,LTD.
- North American market
- FCC equipment authorization FDA 510(k) clearance FDA medical device registration
- Representative tenure
- In office since 2014-03 (12 yrs)
Certifications 14
- Medical device license (Class II) (794)Official registry Valid until 2027-09-18 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2025-01-30 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2027-08-03 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2027-08-08 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2030-08-23 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2029-07-21 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2028-07-04 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2029-06-29 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2028-11-01 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2031-01-10 · Taiwan Food and Drug Administration (TFDA)
- FDA (53)Self-reported
- GMP (261)Self-reported
- ISO 13485 (310)Self-reported
- ISO 27001 (292)Self-reported
Processes & materials 6
- Colorectal Condition Screening (1) · Extracted from websiteSelf-reported
- Arrhythmia Diagnosis (1) · Extracted from websiteSelf-reported
- ECG Analysis Reporting (1) · Extracted from websiteSelf-reported
- Medical Grade Wearables (1) · Extracted from websiteSelf-reported
- Fecal Occult Blood Test Kit (1) · Extracted from websiteSelf-reported
- Continuous ECG Patch Monitor (1) · Extracted from websiteSelf-reported
Patents 7
- 2023 Physiological information monitoring system
- 2023 Physiological signal sensing device
- 2023 Method for obtaining electrocardiogram data
North American market evidence 3
- FCC equipment authorization 2ATKN 2019-06-03
- FDA 510(k) clearance K213233 2022-06-23
EZYPRO ECG Recorder (Model: UG02) - FDA medical device registration 3025330366 2022-10-20
Transmitters And Receivers, Physiological Signal, Radiofrequency
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