Trinity Biotech
Active in EUDAMEDUnited Statesfrom EUDAMED address EUDAMED SRN US-MF-000035173
- Devices
- 7
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
Catalogue
DeviceDevice · Authorizations Verified Status Regime Registry Class
Lyme B. burgdorferi (IgG) MarStripe Test Ref K163095
Regimes: 510(k) Registry: 510(k)Herpes Group Igg Ref K033059
Regimes: 510(k) Registry: 510(k)Uni-Gold Cryptosporidium Ref K121565
Regimes: 510(k) Registry: 510(k)Rotavirus Eia Ref K964424
Regimes: 510(k) Registry: 510(k)Destiny Max Coagulation Analyzer Ref K083896
Regimes: 510(k) Registry: 510(k)Lyme B. burgdorferi (IgM) MarStripe Test Ref K172254
Regimes: 510(k) Registry: 510(k)Unigold Giardia Ref K120001
Regimes: 510(k) Registry: 510(k)
Company details
- EUDAMED SRN
- US-MF-000035173
- EUDAMED status
- Active
- EUDAMED registered name
- Immco Diagnostics, Inc.
- Website
- www.trinitybiotech.com
- [email protected]
- Phone
- +17166910091
- PRRC contact
- Lee Kroening
Frequently asked questions
How many devices does Trinity Biotech have in the registry?
The registry currently lists 7 devices for Trinity Biotech. Devices recorded under merged duplicate company entries are counted once.
Which registries list Trinity Biotech's devices?
Among its 7 most recently registered devices, Trinity Biotech has devices listed in FDA 510(k) (7 devices).
What risk classes do Trinity Biotech's devices fall under?
Among its 7 most recently registered devices, the classes recorded for Trinity Biotech's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Trinity Biotech in the registry?
The most recently registered devices listed for Trinity Biotech include Lyme B. burgdorferi (IgG) MarStripe Test, HERPES GROUP IGG, UNI-GOLD CRYPTOSPORIDIUM and ROTAVIRUS EIA.