FDA.reportPublic FDA data

UNOMEDICAL A/S

Matched from indexed company URL: UNOMEDICAL, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
80215451000477110UNOMEDICAL A/S1N2026-01-01Aaholmvej 1 - 3 OSTED, LEJRE Sjalland DK 4320
30057784703005778470UNOMEDICAL S.R.O.1N2026-01-01PRIEMYSELNY PARK 3 MICHALOVCE Kosicky SK 07101

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
05705244027015iLet Flex - ilet Flex, 9mm, 80cm 10 pack+18004228811cic12@convatec.com
05705244027046iLet Flex - ilet Flex, 6mm, 46cm 2 pack+18004228811cic12@convatec.com
05705244027060iLet Flex - ilet Flex, 6mm, 60cm 2 pack+18004228811cic12@convatec.com
05705244027107iLet Flex - ilet Flex, 6mm, 80cm 2pack+18004228811cic12@convatec.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
99041316544487K991759MAERSK MEDICAL CONTOUR INFUSION SETFPA1999-06-25
99041493322155K972135MAERSK MEDICAL PURELINE COMFORT SUBCUTANEOUS INFUSION SETFPA1997-08-26
99041634770474K945617PHARMA-PLAST PURELINE(TM) BASIC(TM) AND PURELINE(TM) CONTACT(TM) SUBCUTANEOUS INFUSION SETSFPA1995-02-13
99041125014385K881767VIGGO INSUFLONFOZ1988-08-24
3347121081320490K232665GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14)EZD2024-01-25
3347121763827780K213283GentleCath Air for Men Hydrophilic Intermittent Urinary CatheterGBM2022-06-22
99041932819209K210544Medtronic Extended infusion setFPA2021-07-16
99041252821406K192647neria guard Infusion SetFPA2019-12-13
3347121273045649K181206GentleCath Glide Intermittent Urinary CatheterGBM2018-08-16
99041530715543K173879MiniMed Mio Advance infusion setFPA2018-03-05
99041939259795K162812Unomedical 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 SetFPA2017-11-01
99041095844366K160648MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®FPA2016-08-10
99041598715279K132142NERIA SOFT 90 INFUSION SETFPA2013-10-08
99041667456802K120872ASANTE CONSET AND ASANTE COMFORT SUBCUTANEOUS INFUSION SETS FOR USE WITH ASANTE PEARL INFUSION PUMPSFPA2012-04-20
99041840849829K120395NERIA MULTI SUBCUTANEOUS INFUSION SETFPA2012-05-30
99042069276138K120337I-PORT ADVANCE INJECTION PORTFOZ2012-02-16
99041407896781K070430PARADIGM QUICK-SET II AND QUICK-SET II SUBCUTANEOUS INFUSION SETSFPA2007-04-04
99041576697062K061374INTUITION INFUSION SETSFPA2006-07-31
99041924094123K051264COMFORT AND INSET SUBCUTANEOUS INFUSION SETS FOR USE WITH ABBOTT INFUSION PUMPSFPA2005-09-01
99041156702554K041545CONTACT DETACHFPA2004-06-30
99041099193729K040633CLICK-ONFPA2004-04-01
99041104553153K032854UNOMEDICAL MONICA INFUSION SETFPA2003-10-09
99041393100409K011071PARADIGM QUICK-SET INFUSION SETFPA2001-06-07
99041825802851K002138PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380FPA2000-08-29
3347121192756328
3347121554131193
3347121659894410
3347121777559758
99041780350920
3347121816367477

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FPA212021-07-16
GBM22022-06-22
FOZ22012-02-16
EZD12024-01-25

PMN#

GUDID#

88 records. Showing 1-40. Next