3D GLOBAL BIOTECH INC.

Unified Business No.

24782320

Industry

Other Manufacturing (2,432)

Main products

Medical devices & supplies (878)

Location

21F.-1, NO.99, SEC. 1, XINTAI 5TH RD., XIZHI DIST., NEW TAIPEI CITY 22175, TAIWAN, R.O.C.↗
New Taipei City (16,829) · Xizhi Dist. (1,300)

Listing

Emerging stock (TPEx) (359) 6808

Organisation type

Company Limited by Shares

Founded

2014-12-26

Paid-in capital

NT$ 778,400,000

Representative

Ou Keng-lieng

Phone

02-2697-1270

Website

https://www.3dglobalbiotech.com.tw/

Exporter

Yes — registered with the Trade Administration

Annual revenue band

NT$20–100M

Ownership

Individually held

North American market

FDA 510(k) clearance FDA medical device registration

Representative tenure

In office since 2017-06 (9 yrs); last handover 2017-06

Growth & profitability

Revenue 2026-09 YoY -65.9%, year-to-date -49.5%
Gross margin 75.1%, operating margin -23.9%, net margin -21.5% (2026-Q2 YTD)

Certifications 10

• Medical device license (Class I) (1,430)Official registry Valid until 2030-12-03 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2027-01-25 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2024-08-15 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-01-15 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-11-19 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-01-17 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-09-24 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-10-09 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2025-04-25 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2025-04-25 · Taiwan Food and Drug Administration (TFDA)

Processes & materials 3

• Ceramics (438) · InorganicSelf-reported
• Testing & inspection (1,056) · Assembly & inspectionSelf-reported
• Surface treatment (576) · Surface treatmentSelf-reported

Patents 8

• 2026 Double-sided dry hydrogel dressing
• 2025 Manufacturing method for sterile bioink
• 2024 Method for three-dimensionally culturing cells using cell growth-promoting colloid, method for mass-producing high-concentration extracellular composition using the method, and use thereof

North American market evidence 3

• FDA 510(k) clearance K212803 2022-05-23
  DailyMate Orthodontic Aligner System
• FDA 510(k) clearance K191774 2019-09-30
  SmileAlign Orthodontic Aligner System
• FDA medical device registration 3031092085 2024-04-14 – 2025-02-04
  Dressing, Wound, Hydrogel Without Drug And/Or Biologic; Lenses, Soft Contact, Daily Wear; Lens, Contact, (Disposable) and more (4)

Government programs & awards 2

• SBIR (Small Business Innovation Research) program 2018 · Ministry of Economic Affairs Small & Medium Enterprise and Startup Administration
• SBIR (Small Business Innovation Research) program 2016 · Ministry of Economic Affairs Small & Medium Enterprise and Startup Administration

Recent changes 1

• 2027-01-25
  Certification expiry · UpcomingMedical device license (Class I) certificate expires on 2027-01-25

RSS feed · Recent changes at Taiwanese manufacturers →

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