Quality Management System

ISO 13485 QUALITY SYSTEM CERTIFICATION
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US FDA GOOD MANUFACTURING PRACTICE (GMP)
We are fully compliant with 21 CFR Part 820, US FDA Quality Systems Regulations.
About FDA GMP

Product Certifications and Approvals

CANADA- Medical Device License
Download Medical Device License

AUSTRALIA – ARTG Certificate
Download ARTG Certificate

EUROPE – CE Marking certificate
Download CE Marking certificate

Global Regulatory Representatives

Shown below are our in-country representatives for regulatory affairs issues and incident reporting.

AUSTRALIA Sponsor Representative
Emergo Australia, Sydney, AUSTRALIA
Telephone: +61.2.9006.1662
Emergo Group Website

CHINA Legal Agent & After Sales Agent
Jyton & Emergo Co. Ltd., Beijing, CHINA
Telephone: +86.10.8260.9650
Emergo Group Website

EUROPE Authorized Representative
Emergo Europe, The Hague, NETHERLANDS
Telephone: +31.70.345.8570
Emergo Group Website

Notified Body / Registrar / Certification Body

AccuVein maintains ISO 13485:2016 certification and is audited every year by:

BSI Group
12110 Sunset Hills Road
Suite 200
Reston, Virginia 20190
1-800-862-4977
View Certificate
About BSI

Product Patents

AccuVein’s U.S. patents issued include:

  1. US7904138: Micro Vein Enhancer
  2. US7983738: Three Dimensional Imaging of Veins
  3. US8073531: Micro Vein Enhancer
  4. US8150500: Micro Vein Enhancer
  5. US8244333: Scanned Laser Vein Contrast Enhancer
  6. US8255040: Micro Vein Enhancer
  7. US8295904: Micro Vein Enhancer
  8. US8328368: Projection System
  9. US8380291: Scanned Laser Vein Contrast Enhancer
  10. US8391960: Scanned Laser Vein Contrast Enhancer
  11. US8478386: Practitioner-mounted micro vein enhancer
  12. US8463364: Vein Scanner
  13. US8489178: Enhanced laser vein contrast enhancer with projection of analyzed vein data
  14. US8594770: Multispectral detection and presentation of an object’s characteristics
  15. US8750970: Micro Vein Enhancer
  16. US8706200: Scanned Laser Vein Contrast Enhancer
  17. US8665507: Module Mounting Mirror Endoscopy
  18. US8712498: Micro Vein Enhancer
  19. US8730321: Automatic Alignment of Contrast Enhancement System
  20. US8838210: Scanned laser vein contrast enhancer using a single laser
  21. US9125629: Vial-mounted Micro Vein Enhancer
  22. US8818493: Three-dimensional imaging of veins
  23. US9072426: Device for detecting and illuminating vasculature using an FPGA
  24. US9042966: Three dimensional imaging of veins 
  25. US9061109: Vein scanner with user interface
  26. US9186063: Scanned laser vein contrast enhancer…
  27. US9226664: Scanned laser vein contrast enhancer using a single laser
  28. US9345427: Method of using a combination vein contrast enhancer and bar code scanning device
  29. US9492117: Practitioner-mounted micro vein enhancer
  30. US9789267: Vein scanner with user interface
  31. US9949688: Micro vein enhancer with a dual buffer mode of operation
  32. US9044207: Micro vein enhancer for use with a vial holder
  33. US9788787: Patient-mounted micro vein enhancer
  34. US9788788: Three dimensional imaging of veins
  35. US9760982: Automatic alignment of contrast enhancement system
  36. US9782079: Device for detecting and illuminating the vasculature using an FPGA
  37. US9854977: Scanner laser vein contrast enhancer using a single laser and modulation circuitry
  38. US9430819: Automatic alignment of contrast enhancement system
  39. US9558678: Near-infrared imager training device
  40. US10096096: Automatic Alignment of a contrast enhancement system
  41. US10258748: Vein scanner with user interface for controlling imaging parameters
  42. US10357200: Scanning laser vein contrast enhancer having releasable handle and scan head
  43. US10299721: Scanned laser vein contrast enhancer using one laser 
  44. US10376148: System and method for laser imaging and ablation of cancer cells using fluorescence 
  45. US10376147: System and method for multi-color laser imaging and ablation of cancer cells using fluorescence
  46. US10238294: Scanned laser vein contrast enhancer using one laser 
  47. US10470706: Micro vein enhancer for hands-free imaging for a venipuncture procedure
  48. US10539631: Charge-carrier hall-effect sensor
  49. US10299721: Scanned laser vein contrast enhancer using one laser
  50. US10500350: Combination vein contrast enhancer and bar code scanning device
  51. US10518046: Vein scanner with user interface
  52. US9072426: Device for detecting and illuminating vasculature using an FPGA 
  53. US10517483: System for detecting fluorescence and projecting a representative image 

Worldwide Patents issued include:

  1. EP1981395B1: Micro vein enhancer
  2. EP2454989A1: Micro vein enhancer
  3. EP2124750A4: Scanned laser vein contrast enhancer
  4. EP2124728A4: Enhanced laser vein contrast enhancer
  5. EP1981395A2: Micro vein enhancer
  6. EP2124750A2: Scanned laser vein contrast enhancer
  7. EP2124728A2: Enhanced laser vein contrast enhancer
  8. Japan – 5768094: 小型静脈像エンハンサ及び標的領域の皮下血管を撮像するための装置
  9. Mexico – 295413:  REALZADOR DE VENAS MINIATURIZADO
  10. Mexico – 314914: REALZADOR DE VENAS MINIATURIZADO
  11. Taiwan – I481388:  Micro vein enhancer

Over 50 Additional Patents are Pending