Regulatory

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. US9816063: 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

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