Skip to content
devi
CERTS
Devices
Categories
Manufacturers
Importers
Certifiers
Authorities
Reps.
Representatives
Results for “eUnity”
Name, manufacturer or identifier
Search
Manufacturer
(optional)
Filters
Filters
Registry
EUDAMED
1
FDA 510(k) incl. De Novo
3
FDA PMA
GUDID
1
Country / market
United States
4
Risk class
Class I
Class IIa
Class IIb
Class III
Class II (US)
4
More classes (11)
Class A
Class B
Class C
Class D
IVD General
IVD Annex II List A
IVD Annex II List B
IVD for self-testing
Active implantable (AIMDD)
Unclassified (FDA)
Not classified (FDA)
Verified
Verified only
Category (EMDN)
Browse by category
Apply filters
4 devices found
·
sorted by relevance
Key
Clear all
Device
Device · Manufacturer · Authorizations
Verified
Verified
Status
Status
Regime
Regime
Registry
Registry
Class
Class
eUnity-1
Mach7 Technologies Canada Inc
·
,
FDA registration: Canada
CE/MDR
GUDID
on market
Active
Regimes:
CE MDR
Registry:
EUDAMED
GUDID
Class
Class:
II
eUnity
Client Outlook, Inc.
·
,
Canada
(FDA applicant)
Group of variants
FDA 510(k)
K161515
Active
Cleared 15 Nov 2016
Active
Regimes:
510(k)
Registry:
510(k)
Class
Class:
II
Previous
Next
Showing 1-4 of 4