Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8021545

FEI Number

1000477110

Entity Name

UNOMEDICAL A/S

City/State/Country

OSTED, LEJRE Sjalland, DK

Establishment Address

Aaholmvej 1 - 3, OSTED, LEJRE Sjalland 4320, DK

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

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

K945617

PMA Number

N/A

All Registered Proprietary Names

Silhouette® Paradigm® MiniMed Silhouette Infusion set Silhouette® (Luer Lock) VariSoft Accu-Chek TenderLink Comfort Accu-Chek Tender Comfort Short Autosoft XC AutoSoft90 MiniMed Mio Advance iLet Flex Medtronic Extended infusion set contact detach TruSteel neria guard MiniMed Mio Infusion set Sure-T® Paradigm® MiniMed Quick set Infusion set Quick-set® Paradigm® MiniMed Sure T Infusion set Mio®

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2020-05-07
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2008-02-05
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2018-03-06
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2021-09-07
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2008-02-08
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	2019-12-19
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
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	2008-02-05
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2008-02-04

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
3003442380	Unomedical Devices S.A de C.V	Reynosa Tamaulipas, MX

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
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
K982672	Baxter Healthcare Corp	COLLEAGUE PUMP SYRINGE ADAPTER SET	1998-09-04
K143446	Roche Diagnostics GmbH	Accu-Chek FlexLink Plus infusion set	2015-08-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
Z-0013-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device; Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.

Similar Registrations

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1047843	ISOMEDIX OPERATIONS INC.	SPARTANBURG, SC, US
3002807090	Sterigenics Germany GmbH	Wiesbaden Hesse, DE
3013319212	ICU MEDICAL, INC.	Lake Forest, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8021545. Last updated year: 2026. Please use registration number 8021545 when referencing this establishment in official correspondence.