Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003442380

FEI Number

3003442380

Entity Name

Unomedical Devices S.A de C.V

City/State/Country

Reynosa Tamaulipas, MX

Establishment Address

Avenida Fomento Industrial Lote 9 Manzana 3, Parque Industrial Del Norte, Reynosa Tamaulipas C.P. 88736, MX

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Convatec, Inc. (Owner Number: 8021535)

Owner / Operator Contact Address

7815 National Service Road, Suite 600, Greensboro, NC 27409, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MiniMed Mio Infusion set Sure-T® Paradigm® MiniMed Quick set Infusion set Quick-set® Paradigm® MiniMed Sure T Infusion set Mio® AutoSoft30 Silhouette® Paradigm® MiniMed Silhouette Infusion set Silhouette® (Luer Lock) VariSoft Accu-Chek TenderLink Comfort Accu-Chek Tender Comfort Short YpsoPump Inset DANA inset II MiniMed Mio 30 Infusion Set MiniMed Mio 30 contact detach TruSteel

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2008-02-05
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2012-06-26
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2018-02-16
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2008-02-08
KZH	Introducer, Syringe Needle	General Hospital	Class 2	880.6920	2008-02-08
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2014-02-11
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2020-05-07
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2012-03-05
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2008-02-04
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2019-08-28
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2008-02-08

Official Correspondent

Jared Ragone

US Agent Details

Courtney Smith Business: ConvaTec Email: courtney.smith@convatec.com Phone: (603) 2470255

Related Public Records

Same Entity

Convatec, Inc.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
8021545	UNOMEDICAL A/S	OSTED, LEJRE Sjalland, DK

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K943349	Quinton, Inc.	MAHURKAR DUAL LUMEN CATHETER	1995-03-22
K912158	Medical Device Inspection Co., Inc.	CENTRAL VENOUS CATHETER DRESSING CHANGE TRAY	1991-10-23
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02
K972493	Nipro Medical Corp.	NIPRO DISPOSABLE SOLUTION INFUSION SET	1997-09-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2024	ARROW INTERNATIONAL Inc.	2	Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0003-2024	ARROW INTERNATIONAL Inc.	2	Arrow Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0009-2023	B Braun Medical Inc	2	Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.
Z-0025-2024	Becton Dickinson Infusion Therapy Systems Inc.	2	REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64 mL/min , Rx Only, Sterile EO
Z-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24

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3013557562	CBR ENTERPRISE LIMITED	Hong Kong, HK
3015859709	Arrow International, LLC (subsidiary of Teleflex Incorporated)	Wyomissing, PA, US
1721676	Sterigenics U.S., LLC	Salt Lake City, UT, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003442380. Last updated year: 2026. Please use registration number 3003442380 when referencing this establishment in official correspondence.