iSMART Developments, Ltd.
Active in EUDAMEDUnited Kingdomfrom SRN EUDAMED FDA SRN GB-MF-000020855
iSMART Developments, Ltd. is a medical device manufacturer based in the United Kingdom, with 56 devices listed in FDA GUDID, FDA 510(k) and EUDAMED (FDA Class II; EU Class IIa) as of 13 Nov 2026.
- Devices
- 56
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA GUDID 53
- FDA 510(k) 3
- EUDAMED 1
- Device classes
- FDA Class II 55
- EU Class IIa 1
- Top EMDN categories
- Identifiers
- EUDAMED SRN GB-MF-000020855
At a glance
EU certificates
0 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA establishment
What iSMART Developments, Ltd. makes
iSMART Developments, Ltd. manufactures cosmetic red-light phototherapy systems, red/infrared light phototherapy units, blue/red/infrared phototherapy lamps, and red/blue light phototherapy units for home and professional use, including devices such as the North American Kandyway Eternal Glow MD-Face, Omnilux Eye Brightener, and Omnilux Contour GLOVE.
Catalogue
Search and filter all 56 devicesShowing 1-50 of 56
Company details
- EUDAMED SRN
- GB-MF-000020855
- EU VAT number
- GB312 4908 24
- EUDAMED status
- Active
- EUDAMED registered name
- iSMART DEVELOPMENTS LIMITED
- EUDAMED abbreviated name
- iSMART
- Registered address
- 129, Green Lanes, B73 5LT, Birmingham, United Kingdom (ex Northern Ireland)
- Website
- ismart.health/
- Phone
- +447889247277
- PRRC contact
- Cinzia Contrino
EUDAMED certificates
1 certificate0 valid, 0 expired, 1 withdrawn or suspendedMDR 1
Kiwa Assurance B.V. 1912 1 certificate
- 20M00084CRT02 Cancelled
Quality management system EU MDR
- Issued
- 9 Mar 2023
- Expires
- 9 Mar 2028
- Reason
- Other
FDA establishments
- iSMART DEVELOPMENTS LIMITED GB
Frequently asked questions
How many devices does iSMART Developments, Ltd. have in the registry?
The registry currently lists 56 devices for iSMART Developments, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list iSMART Developments, Ltd.'s devices?
Among its 50 most recently registered devices, iSMART Developments, Ltd. has devices listed in FDA GUDID (50 devices).
What risk classes do iSMART Developments, Ltd.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for iSMART Developments, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for iSMART Developments, Ltd.?
EUDAMED lists 1 certificate for iSMART Developments, Ltd. (quality management system) under MDR. The most recent was issued on 9 Mar 2023.
What are the newest devices from iSMART Developments, Ltd. in the registry?
The most recently registered devices listed for iSMART Developments, Ltd. include LUMA PRO Plus TN2508, PRIORI Next Generation LED Facemask TN2332, Lumavance LED facemask TN2508 and faceLITE PRO TN2508.
Which FDA establishments are linked to iSMART Developments, Ltd.?
1 FDA establishment is linked to iSMART Developments, Ltd. in the registry; they are listed on the company page.