Unified Business No.

25098389

Industry

Machinery & Equipment (12,724)

Main products

Other special-purpose machinery (3,243)

Location

1 F., No. 26, Sec. 2, Shengyi Rd., Zhubei City, Hsinchu County 30261, Taiwan (R.O.C.)↗
Hsinchu County (1,617) · Zhubei City (468)

Listing

Listed (TPEx) (890) 6767

Registration status

Approved / Active

Organisation type

Company Limited by Shares

Founded

2009-12-29

Paid-in capital

NT$ 391,836,300

Representative

Liang Huang-chien

Phone

03-6107168

Website

https://www.wiltrom.com.tw/

Exporter

Yes — registered with the Trade Administration

Annual revenue band

NT$100–500M

Ownership

Group subsidiary / corporate-held · INTAI TECHNOLOGY CORP.

North American market

FDA 510(k) clearance FDA medical device registration

Representative tenure

In office since 2016-07 (10 yrs); last handover 2016-07

Growth & profitability

Revenue 2026-09 YoY +23.8%, year-to-date +0.9%
Gross margin 77.5%, operating margin 1.4%, net margin -0.4% (2026-Q2 YTD)

Compliance record

FDA import refusal: 2 product(s), latest 2024-09-04

Plants 2

• Zhubei Plant 2 · 8F, No. 130, Sec. 2, Shengyi Rd. (Hsinchu Science Park), Zhubei City, Hsinchu County↗ In production
• Zhubei Plant · 1F, No. 26, Sec. 2, Shengyi Rd. (Hsinchu Science Park), Zhubei City, Hsinchu County↗ In production

Certifications 32

• Medical device license (Class I) (1,430)Official registry Valid until 2025-09-07 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2022-11-09 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2031-01-05 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-04-01 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-05-23 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-05-23 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-01-02 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-02-12 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-12-08 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-12-08 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-05-12 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-06-17 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-08-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-10-30 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-04-29 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-06-15 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-07-18 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-04-29 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-02-12 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-02-12 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-04-29 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-12-08 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-03-09 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2021-10-13 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2015-08-05 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-03-09 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-03-29 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-03-09 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-04-01 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2015-07-22 · Taiwan Food and Drug Administration (TFDA)
• GMP (261)Self-reported
• ISO 13485 (310)Self-reported

Patents 7

• 2023 Bone filling material delivery device
• 2022 Hole-expanding device
• 2021 Operating tool for vertebral body distraction implant

North American market evidence 7

• FDA 510(k) clearance K202894 2020-10-23
  Wiltrom Spinal Fixation System
• FDA 510(k) clearance K180758 2018-10-24
  Osteocera Resorbable Bone Substitute
• FDA 510(k) clearance K172237 2018-02-02
  Bicera Resorbable Bone Substitute
• FDA 510(k) clearance K172548 2018-01-12
  Wiltrom Spinal Fixation System
• FDA 510(k) clearance K110949 2012-09-18
  BICERA (TM) RESORBABLE BONE SUBSTITUTE
• FDA medical device registration 3011964577 2018-02-09 – 2020-12-07
  Orthopedic Manual Surgical Instrument; Filler, Bone Void, Calcium Compound; Thoracolumbosacral Pedicle Screw System
• FDA import refusal 3011964577 2024-09-04
  SCREW, FIXATION, BONE; WASHER, BOLT, NUT

Government programs & awards 1

• SBIR (Small Business Innovation Research) program 2015 · Ministry of Economic Affairs Small & Medium Enterprise and Startup Administration

Similar companies 10

• PIHSIANG MACHINERY MANUFACTURING CO., LTD. · Hsinchu County NT$1–5B estimated
  Shared: Medical device license (Class II), GMP, ISO 13485, Other medical devices & supplies manufacturing n.e.c.
• RE-TOK INDUSTRIES INC. · New Taipei City NT$20–100M estimated
  Shared: Medical device license (Class II), GMP, Medical equipment wholesale
• MERITS HEALTH PRODUCTS CO., LTD. · Taichung City NT$0.5–1B estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c.
• RECO-DENT INTERNATIONAL CO., LTD. · New Taipei City NT$20–100M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c.
• AIR CLEAN DEVISER TAIWAN CORP. · Taichung City NT$20–100M estimated
  Shared: Medical device license (Class II), Other professional, scientific & technical services n.e.c., Other medical devices & supplies manufacturing n.e.c.
• BECQUEREL & SIEVERT CO., LTD. · New Taipei City NT$100–500M estimated
  Shared: Medical device license (Class I), Medical device license (Class II)
• HERON NEUTRON MEDICAL CORP. · Hsinchu County Listed (TWSE) < NT$20M
  Shared: Medical device license (Class II), ISO 13485, Medical equipment wholesale
• PEGAVISION CORPORATION · Taoyuan City Listed (TWSE) ≥ NT$5B
  Shared: Medical device license (Class I), Medical device license (Class II), GMP, ISO 13485
• HMD BIOMEDICAL INC. · Hsinchu County Public company (unlisted) NT$100–500M
  Shared: Medical device license (Class I), Medical device license (Class II), GMP, ISO 13485
• SHI HENG TECHNOLOGY CO., LTD. · New Taipei City NT$20–100M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c.

Open in advanced filters →