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SYNTEC SCIENTIFIC CORPORATION

亞太醫療器材科技股份有限公司

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1Plants

107Certifications

6Patents

NT$100–500MRevenue band (est.)

Unified Business No.: 89788071
Industry: Other Manufacturing (2,436)
Main products: Medical devices & supplies (878)
Location: NO. 2, GONG 3RD RD., XIDI VIL., SHENGANG TOWNSHIP, CHANGHUA COUNTY, TAIWAN (R. O. C.)
Changhua County (11,429) · Shengang Township (513)
Listing: Not publicly issued (84,625)
Organisation type: Company Limited by Shares
Representative: Chang Yu-ting
Phone: 04-7987099
Exporter: Yes — registered with the Trade Administration
Annual revenue band: NT$100–500M estimated
Ownership: Family-run (inferred)
North American market: FDA 510(k) clearance FDA medical device registration
Representative tenure: In office since 2025-10 (1 yrs); last handover 2025-10

Certifications 107

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 2028-03-29 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2027-11-29 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2031-04-13 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2022-08-22 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2031-05-03 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2030-12-22 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2031-10-05 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2027-12-13 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2027-07-13 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2027-07-13 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2027-06-30 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2027-07-27 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2027-08-02 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2027-08-02 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2027-08-04 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-08-30 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-07-10 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-08-14 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2024-04-17 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-06-23 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2026-12-31 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2027-04-20 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2027-04-22 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-08-17 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-02-05 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2031-01-17 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2031-02-17 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-08-15 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-03-14 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-03-25 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-05-17 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-07-13 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-11-21 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2031-02-24 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2031-04-16 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-09-13 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2027-10-02 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-08-21 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-08-21 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-08-28 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-08-28 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-08-28 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-08-28 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-08-28 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-09-02 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-10-21 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-02-09 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-02-09 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-02-09 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-02-09 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-02-09 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-02-09 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-02-09 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-02-09 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-04-27 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-04-30 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-05-13 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-04-05 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-05-06 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2027-06-07 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2027-07-18 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-04-17 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-01-21 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2027-01-23 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-12-09 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-12-09 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-12-29 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2031-09-13 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2031-09-29 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2031-10-31 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-06-07 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-11-30 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-12-07 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-09-01 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-12-08 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-12-22 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2027-03-08 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2027-05-18 · 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 2031-09-02 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2031-10-05 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2031-11-11 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2027-01-04 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2027-04-25 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2027-06-17 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2027-07-16 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-03-10 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-04-01 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-11-16 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-11-23 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-09-01 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-01-22 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-02-21 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-04-26 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-06-01 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-06-04 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2031-04-26 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2027-11-02 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2031-10-02 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-07-25 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class III) (94)Official registry Valid until 2029-12-08 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class III) (94)Official registry Valid until 2030-02-19 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class III) (94)Official registry Valid until 2028-06-09 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class III) (94)Official registry Valid until 2026-12-28 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class III) (94)Official registry Valid until 2031-11-11 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class III) (94)Official registry Valid until 2029-07-30 · Taiwan Food and Drug Administration (TFDA)

Patents 6

2026 Proximal tibial step-type bone plate
2025 Four-corner locking hole multi-axis angle plate
2024 Elastic intramedullary nail

North American market evidence 20

FDA 510(k) clearance K202790 2021-09-17
Syntec Orthodontic Mini Screw Extended System
FDA 510(k) clearance K202935 2020-10-28
Syntec Femoral Nail Extended System
FDA 510(k) clearance K200933 2020-05-05
Syntec Non-Sterile Steinmann Pins System
FDA 510(k) clearance K191617 2019-09-03
Syntec Tibial Nail System
FDA 510(k) clearance K181296 2019-04-11
Syntec Femoral Nail System
FDA 510(k) clearance K161327 2017-06-08
SYNTEC HUMERAL NAIL SYSTEM
FDA 510(k) clearance K111189 2012-12-20
SYNTEC DENTAL IMPLANT
FDA 510(k) clearance K101971 2011-03-25
SYNTEC OS SPINAL FIXATION SYSTEM
FDA 510(k) clearance K092889 2010-06-25
SYNTEC OSTEO-PLATE AND SCREW FIXATION
FDA 510(k) clearance K090476 2009-06-18
SYNTEC ORTHODONTIC MINI SCREW
FDA 510(k) clearance K090839 2009-04-24
MODIFICATION TO SYNTEC-TAICHUN NON-STERILE BONE PLATE AND SCREW IMPLANTS
FDA 510(k) clearance K984602 1999-03-05
SYNTEC-TAICHUNG NON-STERILE UNREAMED INTERLOCKING NAIL SYSTEM
FDA 510(k) clearance K984364 1999-03-02
SYNTEC-TAICHUNG NON-STERILE SMALL ORTHOPEDIC FIXATION SYSTEM, MODEL 71100, 294-300,400 & 292-730/820
FDA 510(k) clearance K984543 1999-03-01
SYNTEC-TAICHUNG NON-STERILE INTERLOCKING NAIL SYSTEM, MODEL:HUMERUS:256-000/280, FEMUR:274-000/870, TIBIA:249-300/420 25
FDA 510(k) clearance K983988 1999-01-27
SYNTEC-TAICHUNG NON-STERILE TITANIUM ALLOY MINI-PLATE
FDA 510(k) clearance K983873 1998-12-30
SYNTEC-TAICHUNG NON-STERILE DHS/DCS PLATE SYSTEM
FDA 510(k) clearance K983495 1998-12-16
SYNTEC-TAICHUNG NON-STERILE BONE PLATE AND SCREW IMPLANTS, MODEL#'S 222020-248120, 240050-240980, 241130-246620, 4240420
FDA 510(k) clearance K983757 1998-12-04
SYNTEC-TAICHUNG NON-STERILE KNOWLES PIN, MODELS: FOR HEXAGONAL COLLAR: 2991-01/15,2992-01/15, FOR SQUARE COLLAR:29992-01
FDA 510(k) clearance K983121 1998-10-05
NON-STERILE KIRSCHNER WIRES AND STEINMANN PINS, MODELS #'S 290-101/160, 290-201/216, 290-060/330, 290-161/220
FDA medical device registration 9616944 2009-03-19 – 2026-05-28
Plate, Fixation, Bone; Screw, Fixation, Bone; Rod, Fixation, Intramedullary And Accessories and more (44)

Recent changes 4

2027-01-23
Certification expiry · UpcomingMedical device license (Class II) certificate expires on 2027-01-23
2027-01-04
Certification expiry · UpcomingMedical device license (Class II) certificate expires on 2027-01-04
2026-12-31
Certification expiry · UpcomingMedical device license (Class II) certificate expires on 2026-12-31
2026-12-28
Certification expiry · UpcomingMedical device license (Class III) certificate expires on 2026-12-28

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