APOZA ENTERPRISE CO., LTD.

Unified Business No.

23627146

Industry

Computers, Electronics & Optical Products (2,116)

Main products

Radiation & electro-medical equipment (120)

Location

6 F, No. 657-2, 657-3, 657-5, 657-6, Chung-Cheng Road, Hsin-Chuang District, New Taipei City 242, Taiwan, R.O.C.↗
New Taipei City (16,829) · Xinzhuang Dist. (2,990)

Listing

Not publicly issued (84,625)

Organisation type

Limited Company

Representative

Hsu Ying-chieh

Phone

02-29010620

Website

http://www.apoza.com/

Exporter

Yes — registered with the Trade Administration

Annual revenue band

< NT$20M estimated

Ownership

Individually held

North American market

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

Representative tenure

In office since 2021-02 (5 yrs); last handover 2021-02

Certifications 13

• Medical device license (Class I) (1,430)Official registry Valid until 2021-09-21 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2010-09-27 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2026-12-28 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2028-12-18 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2010-10-28 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2016-06-01 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2010-11-21 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2011-04-27 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2011-12-28 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-09-28 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-10-05 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2015-10-06 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-12-23 · Taiwan Food and Drug Administration (TFDA)

Processes & materials 6

• Dental Medical (1) · Extracted from websiteSelf-reported
• LED Curing Light (1) · Extracted from websiteSelf-reported
• GP Obturator (1) · Extracted from websiteSelf-reported
• Autoclave (1) · Extracted from websiteSelf-reported
• Bleaching Unit (1) · Extracted from websiteSelf-reported
• Ozone Therapy Device (1) · Extracted from websiteSelf-reported

North American market evidence 6

• FDA 510(k) clearance K041303 2004-06-18
  LED TURBO-PEN
• FDA 510(k) clearance K033198 2004-04-30
  APOZA ULTRASONIC SCALER AND EDODONTICS UNIT, SELECTOR U2
• FDA 510(k) clearance K040618 2004-03-25
  LED TURBO
• FDA 510(k) clearance K033201 2003-12-02
  LA500 BLUE LIGHT
• FDA medical device registration 9680864 1994-11-30 – 2014-07-29
  Activator, Ultraviolet, For Polymerization; Heat Source For Bleaching Teeth; Plugger, Root Canal, Endodontic and more (7)
• Health Canada medical device licence 125286

Recent changes 1

• 2026-12-28
  Certification expiry · UpcomingMedical device license (Class I) certificate expires on 2026-12-28

RSS feed · Recent changes at Taiwanese manufacturers →

Similar companies 9

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• HJ DigiHealth Co. Ltd. · Taipei City < NT$20M estimated
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• MITSMED MEDICAL INSTRUMENT TECHNOLOGY CO., LTD. · Taoyuan City < NT$20M estimated
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• DELBIO, INC. · Taoyuan City < NT$20M estimated
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