PENG LIM ENTERPRISE CO., LTD.

Unified Business No.

83627155

Industry

Other Manufacturing (2,432)

Main products

Medical devices & supplies (878)

Location

No. 42, Wanxing St., Sanmin Dist., Kaohsiung City 80794, Taiwan (R.O.C.)↗
Kaohsiung City (7,253) · Sanmin Dist. (219)

Listing

Not publicly issued (84,625)

Registration status

Approved / Active

Organisation type

Limited Company

Founded

1977-07-25

Paid-in capital

NT$ 8,000,000

Representative

Wang Chin-shih

Phone

07-3953080

Website

https://www.penglim.com.tw/

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 2023 (2+ years)

Plants 2

• Plant · No. 17, Zhongfeng St., Sanmin Dist., Kaohsiung City↗ In production
• Wanxing Plant · No. 42, Wanxing St., Sanmin Dist., Kaohsiung City↗ In production

Certifications 27

• Medical device license (Class I) (1,430)Official registry Valid until 2020-12-18 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2026-10-31 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2026-10-31 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2016-08-09 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2025-06-01 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2022-06-19 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2020-09-26 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2010-10-18 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2020-09-26 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2010-10-20 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2013-07-16 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2013-07-25 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2025-01-26 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2029-05-01 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2022-10-31 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2025-10-31 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2023-04-08 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2023-04-08 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2022-01-19 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2022-01-26 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2027-01-26 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2022-09-24 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2021-10-24 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2026-09-05 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2022-10-12 · Taiwan Food and Drug Administration (TFDA)
• ISO 13485 (310)Self-reported
• ISO 9001 (4,293)Self-reported

Processes & materials 3

• Stainless steel (903) · MetalSelf-reported
• Rubber & silicone (739) · PolymerSelf-reported
• Polishing (313) · Surface treatmentSelf-reported

North American market evidence 3

• FDA 510(k) clearance K062947 2006-12-14
  HIGH SPEED AIR TURBINE HANDPIECE, MODELS SUPER-AIR AND SUPER-QD SERIES
• FDA 510(k) clearance K061695 2006-09-14
  LED PROLUX 770
• FDA medical device registration 8043296 2006-12-29 – 2015-01-12
  Handpiece, Air-Powered, Dental; Crown, Preformed

Recent changes 4

• 2027-01-26
  Certification expiry · UpcomingMedical device license (Class I) certificate expires on 2027-01-26
• 2026-10-31
  Certification expiryMedical device license (Class I) certificate expired on 2026-10-31
• 2026-09-05
  Certification expiryMedical device license (Class II) certificate expired on 2026-09-05
• 2025-10-31
  Certification expiryMedical device license (Class I) certificate expired on 2025-10-31

RSS feed · Recent changes at Taiwanese manufacturers →

Similar companies 10

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  Shared: Rubber & silicone, Polishing, Medical device license (Class I), ISO 13485
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• IN FUNG CO.LTD · Taichung City NT$100–500M estimated
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