Data / Medical devices / Denmark / Unomedical A/S
Unomedical A/S: FDA-registered device maker in OSTED, LEJRE Sjaelland, Denmark, 14 510(k) clearances
Unomedical A/S is registered with the FDA (registration 8021545) in OSTED, LEJRE Sjaelland, Denmark. It lists 3 device types. The FDA files 14 510(k) clearances under its listings, the newest dated July 16, 2021. 6 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8021545
- FEI number
- 1000477110
- Address
- Aaholmvej 1 - 3, OSTED, LEJRE Sjaelland, Denmark, 4320
- Owner or operator
- Convatec, Inc. (8021535)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- February 4, 2008
- Registered through
- 2026
- Brand names listed
- Accu-Chek TenderLink, Accu-Chek Tender, AutoSoft30, AutoSoft90, Autosoft XC, Comfort Short, Comfort, DANA inset II and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Introducer, Syringe Needle | KZH | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 16, 2021 | K210544 | Medtronic Extended infusion set | FPA | Substantially Equivalent | Unomedical A/S | accessdata.fda.gov |
| December 13, 2019 | K192647 | neria guard Infusion Set | FPA | Substantially Equivalent | Unomedical A/S | accessdata.fda.gov |
| March 5, 2018 | K173879 | MiniMed Mio Advance infusion set | FPA | Substantially Equivalent | Unomedical A/S | accessdata.fda.gov |
| November 1, 2017 | K162812 | Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set, Roche Accu-Chek Tender Subcutaneous Infusion Set, Asante Comfort Subcutaneous Infusion Set, Abbott Comfort Subcutaneous Infusion Set | FPA | Substantially Equivalent | Unomedical A/S | accessdata.fda.gov |
| August 10, 2016 | K160648 | MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio® | FPA | Substantially Equivalent | Unomedical A/S | accessdata.fda.gov |
| October 8, 2013 | K132142 | NERIA SOFT 90 INFUSION SET | FPA | Substantially Equivalent | Unomedical A/S | accessdata.fda.gov |
| May 30, 2012 | K120395 | NERIA MULTI SUBCUTANEOUS INFUSION SET | FPA | Substantially Equivalent | Unomedical Devices S.A DE C.V. | accessdata.fda.gov |
| February 16, 2012 | K120337 | I-PORT ADVANCE INJECTION PORT | FOZ | Substantially Equivalent | Unomedical A/S | accessdata.fda.gov |
| July 31, 2006 | K061374 | INTUITION INFUSION SETS | FPA | Substantially Equivalent | Unomedical A/S | accessdata.fda.gov |
| June 30, 2004 | K041545 | CONTACT DETACH | FPA | Substantially Equivalent | Unomedical A/S | accessdata.fda.gov |
| October 9, 2003 | K032854 | UNOMEDICAL MONICA INFUSION SET | FPA | Substantially Equivalent | Unomedical A/S | accessdata.fda.gov |
| June 25, 1999 | K991759 | MAERSK MEDICAL CONTOUR INFUSION SET | FPA | Substantially Equivalent | Maersk Medical A/S | accessdata.fda.gov |
| February 13, 1995 | K945617 | PHARMA-PLAST PURELINE(TM) BASIC(TM) AND PURELINE(TM) CONTACT(TM) SUBCUTANEOUS INFUSION SETS | FPA | Substantially Equivalent | Pharma-Plast Intl. A/S | accessdata.fda.gov |
| August 24, 1988 | K881767 | VIGGO INSUFLON | FOZ | Substantially Equivalent | Ohmeda Medical | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 23, 2024 | 95224 | Class II | Ongoing | VariSoft Infusion Set, Single Use. | Specific VariSoftTM Infusion Sets were packaged using incorrect secondary packaging (boxes) branded "Trusteel Infusion Set". | accessdata.fda.gov |
| March 5, 2024 | 94217 | Class II | Ongoing | Neria Soft Infusion Set, Product Code 507302, intravascular administration set | Specific lots of Neria Soft Infusion Sets, which have been shipped into the US Market, have been shipped with the incorrect Instruction for Use (IFU) within the final pack. The IFU included is the IFU registered for the Rest of World (ROW) countries. The difference between the US IFU and the ROW IFU is the addition of an intended use section in the ROW IFU. | accessdata.fda.gov |
| October 11, 2023 | 93269 | Class I | Ongoing | VariSoft infusion set, Model Number 1002827 | The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported was damage to the connector piece during manufacturing. This damage results in the connector becoming detached more easily from the insulin set than expected, requiring less force to disconnect than intended. Disconnection, when not detected, for example during sl | accessdata.fda.gov |
| July 21, 2022 | 90719 | Class II | Terminated | Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and 1002824. Infusion sets used with Tandem Insulin Subcutaneous Infusion Pump. | The IFU incorrectly states the insulin fill value of two sizes of cannula which can result in an initial insulin infusion to be fewer units than intended. | accessdata.fda.gov |
| May 21, 2015 | 71332 | Class II | Terminated | Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication. | Unomedical has found that in rare cases the steel needle can break during use, interrupting the delivery of medication including insulin. | accessdata.fda.gov |
| November 7, 2014 | 74242 | Class II | Terminated | Infusion Set, Comfort, 23" Hosp 10; Comfort 13mm, 23", STD 5/5; Comfort 13mm, 23" Hosp 10; Infusion Set, Comfort, 43", Hosp 10; Infusion Set, Comfort, 31", Hosp 10; Comfort 13mm, 31". Hosp 10; Infusion Set, Comfort, 23", | Tubing detachment | accessdata.fda.gov |
Compare with other makers
- All makers of Set, Administration, Intravascular
- All makers of Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- All makers of Introducer, Syringe Needle
Updated September 19, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.