QUALITY MANAGEMENT SYSTEM

US FDA (21 CR Part 820) compliance
We are fully compliant with the US FDA Quality System Regulation.

View our Establishment Registration on the FDA website

Registration Number: 3009668743
FEI Number*: 3009668743
Status: Active
Date Of Registration Status: 2018

*Firm Establishment Identifier (FEI)

Owner/Operator: 
Amenity Health, Inc.
8825 Rehco Rd Suite D
San Diego,  CA  92121
Owner/Operator Number: 10041014

PRODUCT CERTIFICATIONS AND APPROVALS

CANADA- Medical Device Licenses (Health Canada website)
Device 1 | Device 2

EUROPE – CE Marking certificates (PDF format)
Device 1 | Device 2 

UNITED STATES – FDA
Medcline is a class I, 510(k)-exempt device
(Links to US FDA database device listing)
Device 1 | Device 2

MATERIAL SAFETY DATA SHEETS

Device 1 | Device 2 

GLOBAL REGULATORY REPRESENTATIVES

UNITED STATES –
Amenity Health
8825 Rehco Rd. Suite D.
San Diego, California  92121