A-SPINE Asia Co., Ltd.
冠亞生技股份有限公司
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2001Founded
NT$135MPaid-in capital
1Plants
99Certifications
6Patents
NT$100–500MRevenue band
- Unified Business No.
- 12873063
- Industry
- Other Manufacturing (2,432)
- Main products
- Medical devices & supplies (878)
- Location
- 20 F., No. 80, Sec. 1, Chenggong Rd., Yonghe Dist., New Taipei City 234, Taiwan (R.O.C.)
New Taipei City (16,829) · Xindian Dist. (687) - Listing
- Emerging stock (TPEx) (359) 6758
- Organisation type
- Company Limited by Shares
- Founded
- 2001-06-15
- Paid-in capital
- NT$ 134,710,400
- Representative
- Lin Yen-sheng
- Phone
- 02-2926-7088
- Website
- https://www.aspine.com.tw/
- Exporter
- Yes — registered with the Trade Administration
- Annual revenue band
- NT$100–500M
- Ownership
- Group subsidiary / corporate-held · UNITED ORTHOPEDIC CORPORATION
- North American market
- FDA 510(k) clearance
- Representative tenure
- In office since 2017-04 (9 yrs); last handover 2017-04
- Growth & profitability
- Revenue 2026-09 YoY +17.8%, year-to-date +7.0%
Gross margin 77.2%, operating margin 1.7%, net margin 1.5% (2026-Q2 YTD) - Compliance record
- FDA import refusal: 1 product(s), latest 2020-05-20
Labour Standards Act penalties: 2 case(s) in 5 years, latest 2023-11-28, fines NT$ 40,000 (Art. 32; Art. 36) — matched by company name
Certifications 99
- Medical device license (Class I) (1,430)Official registry Valid until 2027-12-07 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2028-01-11 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2024-10-23 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2029-08-01 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2023-01-26 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2030-01-23 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2021-04-13 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2025-08-13 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2028-06-14 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2028-01-11 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2028-07-21 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2031-01-23 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2031-04-01 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2015-12-28 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2023-08-10 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2015-10-26 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2022-03-07 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2019-09-11 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2030-08-12 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2024-05-11 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2029-12-03 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2020-07-13 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2015-12-20 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2024-10-06 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2024-05-30 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2024-12-12 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2029-11-11 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2029-11-07 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2023-07-20 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2030-03-06 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2027-09-22 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2028-09-14 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2027-03-18 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2028-02-23 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2030-08-25 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2031-05-26 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2025-09-10 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2026-02-05 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2028-09-27 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2030-09-07 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2020-09-15 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2031-06-23 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2021-08-01 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2026-12-02 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2027-06-15 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2031-06-21 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2030-08-10 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2030-09-07 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2030-03-09 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2025-03-09 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2030-03-18 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2022-05-18 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2026-05-26 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2031-05-26 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2028-05-04 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2027-10-15 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2028-09-08 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2023-11-05 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2028-12-05 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2028-11-02 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2031-09-30 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2021-01-05 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2027-12-18 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2020-05-03 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2031-09-02 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2021-03-22 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2018-12-25 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2019-03-04 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2029-03-16 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2025-01-19 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2020-07-28 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2029-04-08 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2029-04-14 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2029-04-15 · 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 2016-06-16 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2022-04-03 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2015-03-04 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2031-10-23 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2016-02-06 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2024-08-24 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2027-11-26 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2024-07-08 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2029-06-18 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2014-06-19 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2029-08-28 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2030-07-08 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2030-11-17 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2022-06-26 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2022-10-08 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2022-10-30 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class III) (94)Official registry Valid until 2027-07-31 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class III) (94)Official registry Valid until 2031-05-22 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class III) (94)Official registry Valid until 2025-10-07 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class III) (94)Official registry Valid until 2027-06-30 · Taiwan Food and Drug Administration (TFDA)
- FDA (53)Self-reported
- GMP (261)Self-reported
- ISO 13485 (310)Self-reported
- ISO 9001 (4,293)Self-reported
Processes & materials 3
- Biotechnology (664) · Company nameSelf-reported
- Engineering plastics (204) · PolymerSelf-reported
- Electroplating (567) · Surface treatmentSelf-reported
Patents 6
- 2023 Nerve compression device
- 2022 Composite interbody fusion cage
- 2021 Screw positioning device
North American market evidence 2
- FDA 510(k) clearance K111883 2011-10-18
SMARTLOC SPINAL FIXATION SYSTEM - FDA import refusal 3008876587 2020-05-20
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Recent changes 4
- Certification expiry · UpcomingMedical device license (Class II) certificate expires on 2026-12-02
- Certification expiryMedical device license (Class II) certificate expired on 2026-05-26
- Certification expiryMedical device license (Class II) certificate expired on 2026-02-05
- Certification expiryMedical device license (Class III) certificate expired on 2025-10-07
RSS feed · Recent changes at Taiwanese manufacturers →
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