Advanced Bio-Technologies, Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000037322 FEI 3013057573
- Devices
- 21
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
Catalogue
Kelo-Cote Scar Treatment Ref R/A
Kelo-Cote UV Ref 644279
Kelo-Cote UV Ref 502085
Kelo-Cote UV Ref 524099
Kelo-Cote Spray Ref 591816
Kelo-Cote UV Ref 688183
Kelo-Cote UV Ref 686256
Kelo-Cote Scar Treatment Ref R/A
Kelo-Cote Scar Treatment Ref R/A
Kelo-Cote Topical Gel Ref K002488
Kelo-Cote Spray Ref K053481
Company details
- EUDAMED SRN
- US-MF-000037322
- FDA FEI number
- 3013057573
- EUDAMED status
- Active
- EUDAMED registered name
- Advanced Bio-Technologies
- EUDAMED abbreviated name
- ABT
- Registered address
- 4830, West Kennedy Boulevard, 33609, Tampa, Florida, United States
- Website
- kelocote.com/home/
- [email protected]
- Phone
- +441249466966
- PRRC contact
- Richard Wilkins
What Advanced Bio-Technologies, Inc. makes
Advanced Bio-Technologies, Inc. manufactures topical scar treatments, including formulations for general scar reduction and specialised versions designed for children to prevent and treat scars. The products are applied directly to the skin to minimise the appearance of raised or hypertrophic scars.
These devices are classified as Class I under EU and US regulatory frameworks, with listings in the EUDAMED database and FDA’s 510(k) registry. The company is based in the United States.
Frequently asked questions
How many devices does ADVANCED BIO-TECHNOLOGIES, INC. have in the registry?
The registry currently lists 21 devices for ADVANCED BIO-TECHNOLOGIES, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list ADVANCED BIO-TECHNOLOGIES, INC.'s devices?
Among its 21 most recently registered devices, ADVANCED BIO-TECHNOLOGIES, INC. has devices listed in EUDAMED (19 devices) and FDA 510(k) (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do ADVANCED BIO-TECHNOLOGIES, INC.'s devices fall under?
Among its 21 most recently registered devices, the classes recorded for ADVANCED BIO-TECHNOLOGIES, INC.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from ADVANCED BIO-TECHNOLOGIES, INC. in the registry?
The most recently registered devices listed for ADVANCED BIO-TECHNOLOGIES, INC. include KELO-COTE SCAR TREATMENT, Kelo-Cote UV, Kelo-Cote Spray and KELO-COTE KIDS SCAR PREVENTION AND TREATMENT.