VITALTEC CORPORATION

Unified Business No.

13078796

Industry

Plastic Products (7,565)

Main products

Plastic products (7,635)

Location

No. 12, Lane 4-30, Chyuan-Zhou Rd., Hou-Li Dist., Taichung City 42142, Taiwan↗
Taichung City (17,121) · Houli Dist. (512)

Listing

Not publicly issued (84,625)

Organisation type

Company Limited by Shares

Representative

Chang Ti-li

Phone

04-25580886

Website

https://www.vitaltec-corp.com/en

Exporter

Yes — registered with the Trade Administration

Annual revenue band

< NT$20M estimated

Ownership

Group subsidiary / corporate-held · Hsu Li International Co., Ltd.

North American market

FDA 510(k) clearance FDA medical device registration

Representative tenure

In office since at least 2013 (12+ years)

Certifications 18

• Medical device license (Class I) (1,430)Official registry Valid until 2030-01-09 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2027-01-24 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2029-08-26 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-07-29 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2029-08-19 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2021-05-17 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2027-01-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2016-11-25 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2012-01-12 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2011-11-02 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2017-01-12 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2023-07-02 · 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 2027-08-03 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-03-01 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-02-24 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2015-10-25 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2023-02-22 · Taiwan Food and Drug Administration (TFDA)

Patents 1

• 2024 Sputum suction structure of tracheostomy tube

North American market evidence 5

• FDA 510(k) clearance K253063 2026-09-11
  Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tube (581 Series)
• FDA 510(k) clearance K242921 2025-06-10
  5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm; 5310600-5311000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, Fenestrated, sizes 6.0-10.0mm; 5400600-5401000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, sizes 6.0-10.0mm; 5410500-5411000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, Fenestrated, sizes 6.0-10.0mm
• FDA 510(k) clearance K100480 2010-06-11
  ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH
• FDA medical device registration 3040279832 2025-07-22
  Tube, Tracheostomy (W/Wo Connector)
• FDA medical device registration 3003851906 2003-06-06 – 2013-07-12
  Catheters, Suction, Tracheobronchial; Airway, Oropharyngeal, Anesthesiology; Laryngoscope, Rigid

Recent changes 2

• 2027-01-24
  Certification expiry · UpcomingMedical device license (Class I) certificate expires on 2027-01-24
• 2027-01-10
  Certification expiry · UpcomingMedical device license (Class I) certificate expires on 2027-01-10

RSS feed · Recent changes at Taiwanese manufacturers →

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