Mallinckrodt Dar S.r.l.
ItalyFDA applicant, unverified FDA FEI 3023294726
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Mallinckrodt Dar S.r.l. makes
Mallinckrodt Dar S.R.L. manufactures medical breathing circuits, including heated wire designs, and closed suction systems like the TY-CARE and TY-CARE EXEL for respiratory support applications.
Their products are regulated under FDA 510(k) clearance as Class I and Class II devices, with listings in the FDA’s 510(k) database. The company is based in the United States.
Catalogue
Mallinckrodt Dar Heated Wire Breathing Circuit Ref K993268
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3023294726
- Address
- Unita locale via Caboto 38/40, Reggiolo (RE) Reggio Emilia
Frequently asked questions
How many devices does Mallinckrodt Dar S.R.L. have in the registry?
The registry currently lists 2 devices for Mallinckrodt Dar S.R.L.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Mallinckrodt Dar S.R.L.'s devices?
Among its 2 most recently registered devices, Mallinckrodt Dar S.R.L. has devices listed in FDA 510(k) (2 devices).
What risk classes do Mallinckrodt Dar S.R.L.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Mallinckrodt Dar S.R.L.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Mallinckrodt Dar S.R.L. in the registry?
The most recently registered devices listed for Mallinckrodt Dar S.R.L. include MALLINCKRODT DAR HEATED WIRE BREATHING CIRCUIT and MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEM.