TWDBTaiwan Manufacturer Database 中文

PAONAN BIOTECH CO.,LTD.

寶楠生技股份有限公司

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1985Founded
NT$196MPaid-in capital
2Plants
61Certifications
6Patents
NT$100–500MRevenue band (est.)
Unified Business No.
09479382
Industry
Other Manufacturing (2,432)
Main products
Medical devices & supplies (878)
Location
3 F., No. 50, Ln. 258, Ruiguang Rd., Neihu Dist., Taipei City 11491, Taiwan (R.O.C.)
Taipei City (812) · Neihu Dist. (356)
Listing
Not publicly issued (84,625)
Registration status
Approved / Active
Organisation type
Company Limited by Shares
Founded
1985-05-28
Paid-in capital
NT$ 196,350,000
Representative
Yeh An-shih
Phone
02-2627-4366
Website
https://www.paonan.com.tw/
Exporter
Yes — registered with the Trade Administration
Annual revenue band
NT$100–500M estimated
Ownership
Group subsidiary / corporate-held · Kai Fa Kuo Chi Tou Tzu Co., Ltd.
North American market
FDA 510(k) clearance FDA medical device registration
Representative tenure
In office since 2020-05 (6 yrs); last handover 2020-05 (same surname)

Plants 2

Certifications 61

Processes & materials 3

Patents 6

  • 2025 Spinous process distraction device
  • 2024 Scoliosis correction device capable of automatically adjusting with spine growth
  • 2024 Spinous process suspension type spinal correction device

North American market evidence 7

  • FDA 510(k) clearance K220261 2023-04-24
    NEST-C Interbody System
  • FDA 510(k) clearance K182285 2019-06-20
    PK High Tibial Osteotomy Correction System
  • FDA 510(k) clearance K180230 2019-01-25
    NEST Interbody System
  • FDA 510(k) clearance K180228 2019-01-11
    II-Type Intervertebral Spacer
  • FDA 510(k) clearance K180226 2018-07-25
    TREND II Spinal Fixation System- STEP Series
  • FDA 510(k) clearance K161225 2017-08-11
    Paonan Armstrong Posterior Spinal Fixation System
  • FDA medical device registration 3007887127 2017-11-14 – 2024-02-22
    Intervertebral Fusion Device With Bone Graft, Lumbar; Thoracolumbosacral Pedicle Screw System; Awl and more (21)

Government programs & awards 2

  • SBIR (Small Business Innovation Research) program 2022 · Ministry of Economic Affairs Small & Medium Enterprise and Startup Administration
  • SBIR (Small Business Innovation Research) program 2017 · Ministry of Economic Affairs Small & Medium Enterprise and Startup Administration

Recent changes 6

  • Certification expiry · UpcomingMedical device license (Class II) certificate expires on 2026-12-06
  • Certification expiry · UpcomingMedical device license (Class I) certificate expires on 2026-11-10
  • Certification expiryMedical device license (Class I) certificate expired on 2026-10-31
  • Certification expiryMedical device license (Class II) certificate expired on 2026-08-21
  • Certification expiryMedical device license (Class I) certificate expired on 2026-01-04
  • Certification expiryMedical device license (Class I) certificate expired on 2025-12-29

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