Regulatory

Quality Management System

ISO 13485 QUALITY SYSTEM CERTIFICATION
View Certificate

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

European 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

Over 50 Additional Patents are Pending