Unified Business No.

16704342

Industry

Other Manufacturing (2,432)

Main products

Sporting & recreational goods (630)

Location

No. 66-5, Yaozaizhu, 1st Neighborhood, Xingang Township, Chiayi County 61642, Taiwan (R.O.C.)↗
Chiayi County (1,525) · Xingang Township (72)

Listing

Not publicly issued (84,625)

Organisation type

Limited Company

Representative

Kuo Tsung-fu

Phone

05-3774088

Exporter

Yes — registered with the Trade Administration

Annual revenue band

NT$20–100M estimated

Ownership

Individually held

North American market

FDA 510(k) clearance FDA medical device registration

Representative tenure

In office since at least 2016 (10+ years)

Certifications 25

• Medical device license (Class I) (1,430)Official registry Valid until 2019-11-13 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2019-12-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2027-09-04 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2024-03-28 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2024-04-30 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2027-09-04 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2016-08-02 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2015-12-23 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2015-12-23 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2012-08-17 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2014-02-23 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2014-03-13 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2024-02-01 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2015-03-16 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2015-06-09 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2015-06-09 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2016-05-20 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2018-02-05 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2014-09-15 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2012-08-17 · 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 2021-06-24 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-06-24 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2016-08-23 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2011-10-25 · Taiwan Food and Drug Administration (TFDA)

Patents 1

• 2020 Integrated structure of nasal plug respirator

North American market evidence 2

• FDA 510(k) clearance K042556 2005-03-11
  SHINEBALL PVC MANUAL RESUSCIATOR, ENT-1001, ENT-1003, ENT-1005, SHINEBALL SILICONE MANUAL RESUSCIATOR, ENT-1022,
• FDA medical device registration 3003902679 2003-01-02 – 2025-12-18
  Circuit, Breathing (W Connector, Adaptor, Y Piece); Connector, Airway (Extension); Ventilator, Emergency, Manual (Resuscitator) and more (21)

Similar companies 10

• Faciox Inc. · New Taipei City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c., Medical equipment wholesale
• NANOSIGMA BIOTECH. CO., LTD. · New Taipei City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c., Medical equipment wholesale
• BIO CONCEPT INC. · Taichung City NT$20–100M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c., Medical equipment wholesale
• CHANPIN MEDTAK CO., LTD. · New Taipei City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c., Medical equipment wholesale
• MEM DENTAL TECHNOLOGY CO., LTD. · Tainan City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c., Medical equipment wholesale
• HOME CARE TECHNOLOGY CO., LTD. · Tainan City NT$20–100M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c., Medical equipment wholesale
• TRONJEN MEDICAL TECHNOLOGY INC. · Taichung City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c., Medical equipment wholesale
• SLS MEDICAL TECHNOLOGY CORP. LTD. · Taichung City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c., Medical equipment wholesale
• LARGAN MEDICAL CO., LTD. · Taichung City NT$1–5B estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c., Medical equipment wholesale
• Pan Asia International Medical Devices CO., LTD. · New Taipei City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c., Medical equipment wholesale

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