OMNIMATE ENTERPRISE CO., LTD.

Unified Business No.

28510118

Industry

Other Manufacturing (2,432)

Main products

Medical devices & supplies (878)

Location

No. 8, Ln. 126, Sec. 2, Ligong 1st Rd., Wujie Township, Yilan County 26841, Taiwan (R.O.C.)↗
Yilan County (1,016) · Wujie Township (243)

Listing

Not publicly issued (84,625)

Registration status

Approved / Active

Organisation type

Limited Company

Founded

2006-10-31

Paid-in capital

NT$ 31,000,000

Representative

Tan Chih-hung

Phone

02-29270085

Website

https://www.omnimate.com.tw/

Exporter

Yes — registered with the Trade Administration

Annual revenue band

< NT$20M estimated

Ownership

Individually held

North American market

FDA medical device registration

Representative tenure

In office since 2018-11 (8 yrs); last handover 2018-11

Plants 2

• Plant · No. 8, Ln. 126, Sec. 2, Ligong 1st Rd., Wujie Township, Yilan County↗ In production
• Yilan Plant 2 · No. 3, Ln. 126, Sec. 2, Ligong 1st Rd., Wujie Township, Yilan County↗ In production

Certifications 24

• Medical device license (Class I) (1,430)Official registry Valid until 2023-09-20 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2020-12-21 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2027-12-09 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-10-13 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2020-10-22 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2025-10-28 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2028-02-17 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2031-08-26 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2031-09-06 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2031-09-08 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2024-05-30 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-04-15 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2025-05-18 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2025-09-02 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2028-02-22 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2024-02-12 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-02-27 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2029-08-21 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-10-18 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-11-27 · Taiwan Food and Drug Administration (TFDA)
• CE Marking (162)Self-reported
• GMP (261)Self-reported
• ISO 13485 (310)Self-reported
• ISO 9001 (4,293)Self-reported

Processes & materials 2

• Rubber & silicone (739) · PolymerSelf-reported
• Mould design & manufacturing (644) · MachiningSelf-reported

Patents 3

• 2025 Protective fixator for endotracheal tube
• 2023 Nasogastric tube insertion aid
• 2023 Intubation assist device for medical use

North American market evidence 1

• FDA medical device registration 3009771213 2012-08-27 – 2024-05-13
  Stylet, Tracheal Tube; Airway, Nasopharyngeal; Speculum, Vaginal, Nonmetal and more (15)

Recent changes 1

• 2025-10-28
  Certification expiryMedical device license (Class I) certificate expired on 2025-10-28

RSS feed · Recent changes at Taiwanese manufacturers →

Similar companies 10

• ROLENCE ENTERPRISE INC. · Taoyuan City NT$20–100M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), CE Marking, GMP
• FREE BIONICS TAIWAN INC. · Hsinchu City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), CE Marking, GMP
• PEGAVISION CORPORATION · Taoyuan City Listed (TWSE) ≥ NT$5B
  Shared: Rubber & silicone, Medical device license (Class I), Medical device license (Class II), GMP
• SOMNICS, INC. · Hsinchu County < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), CE Marking, GMP
• I-MING SANITARY MATERIALS CO., LTD. · Changhua County NT$100–500M estimated
  Shared: Rubber & silicone, Medical device license (Class I), Medical device license (Class II), ISO 13485
• APEXLENS CO., LTD. · Hsinchu City < NT$20M estimated
  Shared: Rubber & silicone, Medical device license (Class II), GMP, ISO 13485
• JIANXIN BIOMEDICAL TECHNOLOGY CO., LTD. · Kaohsiung City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Other cosmetics manufacturing n.e.c., Other pharmaceuticals & medical supplies wholesale n.e.c.
• WINNOMED COMPANY LTD. · Taoyuan City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Other pharmaceuticals & medical supplies wholesale n.e.c., Other medical devices & supplies manufacturing n.e.c.
• TAIWAN ONP COMPANY · Taipei City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Other pharmaceuticals & medical supplies wholesale n.e.c., Other medical devices & supplies manufacturing n.e.c.
• CAREMED SUPPLY INC. · Yilan County NT$20–100M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), GMP, ISO 13485

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