KT Health, LLC
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000046404 FEI 3007282994
- Devices
- 1
- Registrations
- EUDAMEDFDA
- FDA recalls
- 1
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI, FDA recalls
- Authorised rep.
- Obelis S.A.BE
What KT Health, LLC makes
KT Health, LLC manufactures reusable device sterilization and disinfection containers, including KT Tape, designed for medical equipment processing.
The company’s products fall under EU Class I medical devices and are registered in the EUDAMED database. KT Health, LLC is based in the United States.
Catalogue
- Regimes: CE MDD Registry: EUDAMED
Company details
- EUDAMED SRN
- US-MF-000046404
- FDA FEI number
- 3007282994
- EU VAT number
- 46-4446188
- EUDAMED status
- Active
- EUDAMED registered name
- KT Health, LLC
- EUDAMED abbreviated name
- KT
- Registered address
- 100 south, 584 East, 84003, American Fork, United States
- Website
- www.kttape.com/
- [email protected]
- Phone
- 8012242717
- PRRC contact
- Doug Sims
FDA recalls
FDA recall records list 1 recall initiated by KT Health, LLC, initiated on 2019-09-16. By recorded status: 1 terminated. The reasons filed fall into these groups: mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 1
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2019
- 16 Sep 2019 Z-1754-2020 Class II Terminated If over-heated may leak which, if not noticed, may cause hot fluid to come in contact with the user.
Frequently asked questions
How many devices does KT Health, LLC have in the registry?
The registry currently lists 1 device for KT Health, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list KT Health, LLC's devices?
Among its 1 most recently registered device, KT Health, LLC has devices listed in EUDAMED (1 device).
What risk classes do KT Health, LLC's devices fall under?
Among its 1 most recently registered device, the classes recorded for KT Health, LLC's devices are Class I. Each device page shows its own class and authorisation.
Are there FDA recall records for KT Health, LLC?
FDA recall records list 1 recall initiated by KT Health, LLC, the most recent initiated on 16 Sep 2019. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from KT Health, LLC in the registry?
The most recently registered devices listed for KT Health, LLC include KT Tape.