POINT ROBOTICS MEDTECH INC.

Unified Business No.

45128565

Industry

Computers, Electronics & Optical Products (2,116)

Main products

Radiation & electro-medical equipment (120)

Location

5F., NO. 130, SEC. 2, SHENGYI RD., ZHUBEI CITY, HSINCHU COUNTY 30261, TAIWAN, R.O.C.↗
New Taipei City (16,829) · Xindian Dist. (687)

Listing

Not publicly issued (84,625)

Organisation type

Company Limited by Shares

Representative

Chuang Hsueh-cheng

Phone

03-6670246

Website

https://www.pointroboticsinc.com/

Exporter

Yes — registered with the Trade Administration

Annual revenue band

< NT$20M estimated

Ownership

Foreign-owned · Cayman Islands · PointRoboticsHoldingLimited (Cayman)

North American market

FDA 510(k) clearance FDA medical device registration

Representative tenure

In office since 2016-07 (10 yrs)

Certifications 9

• Medical device license (Class I) (1,430)Official registry Valid until 2027-01-22 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2028-02-20 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-03-11 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-10-28 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-06-18 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-06-06 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-06-25 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-08-17 · Taiwan Food and Drug Administration (TFDA)
• ISO 13485 (310)Self-reported

Processes & materials 7

• Pedicle screw implantation (1) · Extracted from websiteSelf-reported
• Minimally invasive spinal surgery (1) · Extracted from websiteSelf-reported
• Intraoperative 3D imaging navigation (1) · Extracted from websiteSelf-reported
• Surgical navigation system (1) · Extracted from websiteSelf-reported
• Surgical planning software (1) · Extracted from websiteSelf-reported
• Robotic arm (1) · Extracted from websiteSelf-reported
• Robotic spinal surgery guidance system (1) · Extracted from websiteSelf-reported

Patents 34

• 2026 Fine adjustment alignment device
• 2026 Surgical assist device
• 2025 Surgical system and decompression system

North American market evidence 6

• FDA 510(k) clearance K252989 2026-02-20
  “POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories Set
• FDA 510(k) clearance K252755 2026-01-23
  POINT Kinguide Agile Robotic Arm Surgical Stereotactic System
• FDA 510(k) clearance K241130 2024-07-24
  “POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000)
• FDA 510(k) clearance K230087 2023-07-17
  “POINT” Kinguide Agile Hybrid Navigation System
• FDA 510(k) clearance K220241 2022-08-09
  “POINT” Kinguide Robotic-Assisted Surgical System
• FDA medical device registration 3021976927 2022-11-03 – 2026-02-24
  Orthopedic Stereotaxic Instrument

Government programs & awards 1

• Startup Award – Gold Award 2020 · Ministry of Economic Affairs Small & Medium Enterprise and Startup Administration

Recent changes 1

• 2027-01-22
  Certification expiry · UpcomingMedical device license (Class I) certificate expires on 2027-01-22

RSS feed · Recent changes at Taiwanese manufacturers →

Similar companies 10

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• ACOMED INDUSTRIAL CO., LTD. · New Taipei City < NT$20M estimated
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• ROSSMAX INTERNATIONAL LTD. · Taipei City Listed (TPEx) NT$1–5B
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• MEDICALTEK CO., LTD. · Taichung City < NT$20M estimated
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• SUNRISEMEDICAL CO., LTD. · New Taipei City < NT$20M estimated
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• NORTH-VISION TECH. INC. · Hsinchu City < NT$20M estimated
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• ENERGY RESOURCES INTERNATIONAL CO., LTD · Hsinchu County < NT$20M estimated
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