Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3023294726

FEI Number

3023294726

Entity Name

Mallinckrodt Dar S.r.l.

City/State/Country

Reggiolo (RE) Reggio Emilia, IT

Establishment Address

Unita locale via Caboto 38/40, Reggiolo (RE) Reggio Emilia 42046, IT

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Covidien llc (Owner Number: 1282497)

Owner / Operator Contact Address

15 HAMPSHIRE STREET, --, Mansfield, MA 02048, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Ty-Care/Ty-Care Exel Closed S Airway Connector with Flex Tube SSV Phonate Shiley Speaking Valve Hygrobac Hybrobac S Hygrobaby Hygroboy Sterivent Sterivent S Speaking Valve with Oxygen Port SSVO

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2008-02-15
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2008-02-15
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	Class 2	868.5800	2008-02-15
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2008-02-15
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2008-02-15
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	Class 2	868.5800	2010-01-29

Official Correspondent

No official correspondent registered.

US Agent Details

Kae Miller Business: COVIDIEN LLC Email: kae.miller@medtronic.com Phone: (303) 4081427

Related Public Records

Same Entity

Covidien llc

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
8020889	Mallinckrodt Medical	ATHLONE Westmeath, IE
3006451981	Covidien Medical Products (Shanghai) Manufacturing LLC	Shanghai, CN
8044004	ORIDION MEDICAL 1987 LTD.	JERUSALEM, IL
1282497	Covidien LLC	MANSFIELD, MA, US
9681384	Covidien	Ciudad Juarez Chihuahua, MX

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K962045	Mallinckrodt Medical	ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT	1996-11-26

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3023294726. Last updated year: 2026. Please use registration number 3023294726 when referencing this establishment in official correspondence.