KUNG SHIN PLASTICS CO., LTD.

岡新塑膠工業股份有限公司

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1Plants

18Certifications

NT$20–100MRevenue band (est.)

Unified Business No.: 30971729
Industry: Plastic Products (7,565)
Main products: Plastic products (7,635)
Location: 1 F., No. 61, Jia 5th St., Yingge Dist., New Taipei City 239003, Taiwan (R.O.C.)
New Taipei City (16,829) · Yingge Dist. (571)
Listing: Not publicly issued (84,625)
Organisation type: Company Limited by Shares
Representative: Yang Chien-chih
Phone: 02-26780366
Website: https://www.kungshin.com/
Exporter: Yes — registered with the Trade Administration
Annual revenue band: NT$20–100M estimated
Ownership: Family-run (inferred)
North American market: FDA 510(k) clearance FDA medical device registration
Representative tenure: In office since 2024-12 (1 yrs); last handover 2024-12 (same surname)

Certifications 18

Medical device license (Class I) (1,430)Official registry Valid until 2030-11-26 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2025-12-08 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2023-07-23 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2017-07-05 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2018-04-02 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2012-02-27 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2013-12-12 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2015-07-30 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2015-08-10 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2015-08-10 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2015-08-10 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2022-07-31 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2017-11-26 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2022-01-06 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-02-26 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class III) (94)Official registry Valid until 2016-06-30 · Taiwan Food and Drug Administration (TFDA)
GMP (261)Self-reported
ISO 13485 (310)Self-reported

North American market evidence 2

FDA 510(k) clearance K032878 2004-09-20
KUNG SHIN, HMEF SK203
FDA medical device registration 3004116032 2002-11-08 – 2007-12-03
Filter, Bacterial, Breathing-Circuit; Circuit, Breathing (W Connector, Adaptor, Y Piece); Accessories, Catheter and more (5)

Recent changes 1

2025-12-08
Certification expiryMedical device license (Class I) certificate expired on 2025-12-08

RSS feed · Recent changes at Taiwanese manufacturers →

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