ZMI ELECTRONICS LTD.

Unified Business No.

86057591

Industry

Computers, Electronics & Optical Products (2,116)

Main products

Radiation & electro-medical equipment (120)

Location

12F.-10, No. 12, Fuxing 4th Rd., Qianzhen Dist., Kaohsiung City 80661, Taiwan (R.O.C.)↗
Kaohsiung City (7,253) · Qianzhen (504)

Listing

Not publicly issued (84,625)

Organisation type

Company Limited by Shares

Representative

Lee Chao-nan

Phone

07-815-0053

Website

https://www.zmi-electronics.com/

Exporter

Yes — registered with the Trade Administration

Annual revenue band

NT$20–100M estimated

Ownership

Family-run (inferred)

North American market

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

Representative tenure

In office since at least 2013 (13+ years)

Certifications 33

• Medical device license (188)Official registry Valid until 2010-11-24 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (188)Official registry Valid until 2010-11-29 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (188)Official registry Valid until 2010-11-29 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (188)Official registry Valid until 2008-09-01 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2028-04-12 · Taiwan Food and Drug Administration (TFDA)
• 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 2023-07-19 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2025-05-28 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-08-16 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-01-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-03-24 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2026-10-18 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-07-21 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-05-05 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2021-06-23 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2024-02-09 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2024-02-09 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2019-02-09 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2025-06-12 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-12-03 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-11-29 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2020-11-29 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-11-29 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-12-02 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-05-05 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-02-21 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2021-01-27 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2021-02-06 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2020-07-14 · Taiwan Food and Drug Administration (TFDA)
• CE Marking (162)Self-reported
• GMP (261)Self-reported
• ISO 13485 (310)Self-reported
• RoHS (350)Self-reported

Processes & materials 4

• Rubber & silicone (739) · PolymerSelf-reported
• CNC machining (1,033) · MachiningSelf-reported
• Cleanroom production (392) · Assembly & inspectionSelf-reported
• Laser Engraving (147) · MachiningSelf-reported

Patents 1

• 2019 Shortwave probe device with visual perception biofeedback

North American market evidence 6

• FCC equipment authorization PDS
• FDA 510(k) clearance K241862 2025-03-27
  Levina Pelvic Floor Muscle Stimulator (RS-48)
• FDA 510(k) clearance K231166 2024-01-18
  Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes
• FDA 510(k) clearance K180865 2018-06-28
  ZMI Self-Adhesive Electrodes
• FDA medical device registration 9617486 2008-10-08 – 2025-04-22
  Stimulator, Muscle, Powered; Stimulator, Muscle, Powered, For Muscle Conditioning; Stimulator, Nerve, Transcutaneous, For Pain Relief and more (14)
• Health Canada medical device licence 124828

Recent changes 3

• 2027-01-10
  Certification expiry · UpcomingMedical device license (Class II) certificate expires on 2027-01-10
• 2026-10-31
  Certification expiryMedical device license (Class I) certificate expired on 2026-10-31
• 2026-10-18
  Certification expiryMedical device license (Class II) certificate expired on 2026-10-18

RSS feed · Recent changes at Taiwanese manufacturers →

Similar companies 10

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• LILY MEDICAL CORPORATION · Miaoli County NT$20–100M estimated
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• GEMMY INDUSTRIAL CORP. · New Taipei City < NT$20M estimated
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• ENERGY RESOURCES INTERNATIONAL CO., LTD · Hsinchu County < NT$20M estimated
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• EVERYWAY MEDICAL INSTRUMENTS CO., LTD. · New Taipei City NT$20–100M estimated
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• PO YE X-RAY MFG. CORP. · New Taipei City < NT$20M estimated
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• DI TAI PRECISION ENTERPRISE CO., LTD. · Kaohsiung City < NT$20M estimated
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