UNOMEDICAL A/S

Matched from indexed company URL: Unomedical A

FDA Registration(s)

Registration	FEI	Name	Status	Initial importer	Expiration year	Address
8021545	1000477110	UNOMEDICAL A/S	1	N	2026-01-01	Aaholmvej 1 - 3 OSTED, LEJRE Sjalland DK 4320

GUDID Contact Samples

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

Source GUDID	Product	Phone	Email
05705244026865	iLet Flex - ilet Flex, 6mm, 46cm 10 pack	+18004228811	cic12@convatec.com
05705244026889	iLet Flex - ilet Flex, 6mm, 60cm 10 pack	+18004228811	cic12@convatec.com
05705244026926	iLet Flex - ilet Flex, 6mm, 80cm 10 pack	+18004228811	cic12@convatec.com
05705244026957	iLet Flex - ilet Flex, 9mm, 46cm 10 pack	+18004228811	cic12@convatec.com

convatec.com

Registered Device Listings

Registration key	Listing key	Premarket submission	Device	Product code	Decision date
9904	1316544487	K991759	MAERSK MEDICAL CONTOUR INFUSION SET	FPA	1999-06-25
9904	1493322155	K972135	MAERSK MEDICAL PURELINE COMFORT SUBCUTANEOUS INFUSION SET	FPA	1997-08-26
9904	1634770474	K945617	PHARMA-PLAST PURELINE(TM) BASIC(TM) AND PURELINE(TM) CONTACT(TM) SUBCUTANEOUS INFUSION SETS	FPA	1995-02-13
9904	1125014385	K881767	VIGGO INSUFLON	FOZ	1988-08-24
9904	1932819209	K210544	Medtronic Extended infusion set	FPA	2021-07-16
9904	1252821406	K192647	neria guard Infusion Set	FPA	2019-12-13
9904	1530715543	K173879	MiniMed Mio Advance infusion set	FPA	2018-03-05
9904	1939259795	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	2017-11-01
9904	1095844366	K160648	MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®	FPA	2016-08-10
9904	1598715279	K132142	NERIA SOFT 90 INFUSION SET	FPA	2013-10-08
9904	1667456802	K120872	ASANTE CONSET AND ASANTE COMFORT SUBCUTANEOUS INFUSION SETS FOR USE WITH ASANTE PEARL INFUSION PUMPS	FPA	2012-04-20
9904	1840849829	K120395	NERIA MULTI SUBCUTANEOUS INFUSION SET	FPA	2012-05-30
9904	2069276138	K120337	I-PORT ADVANCE INJECTION PORT	FOZ	2012-02-16
9904	1407896781	K070430	PARADIGM QUICK-SET II AND QUICK-SET II SUBCUTANEOUS INFUSION SETS	FPA	2007-04-04
9904	1576697062	K061374	INTUITION INFUSION SETS	FPA	2006-07-31
9904	1924094123	K051264	COMFORT AND INSET SUBCUTANEOUS INFUSION SETS FOR USE WITH ABBOTT INFUSION PUMPS	FPA	2005-09-01
9904	1156702554	K041545	CONTACT DETACH	FPA	2004-06-30
9904	1099193729	K040633	CLICK-ON	FPA	2004-04-01
9904	1104553153	K032854	UNOMEDICAL MONICA INFUSION SET	FPA	2003-10-09
9904	1393100409	K011071	PARADIGM QUICK-SET INFUSION SET	FPA	2001-06-07
9904	1825802851	K002138	PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380	FPA	2000-08-29
9904	1780350920

Product Codes Associated With Registrations

Product code	Registration listing records	Latest decision
FPA	21	2021-07-16
FOZ	2	2012-02-16

PMN

Medtronic Extended Infusion Set

2021-07-16

Unomedical A/S

Neria Guard Infusion Set

2019-12-13

Unomedical A/s

MiniMed Mio Advance Infusion Set

2018-03-05

Unomedical A/S

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

2017-11-01

UNOMEDICAL A/S

MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®

2016-08-10

UNOMEDICAL A/S

NERIA SOFT 90 INFUSION SET

2013-10-08

UNOMEDICAL A/S

ASANTE CONSET AND ASANTE COMFORT SUBCUTANEOUS INFUSION SETS FOR USE WITH ASANTE PEARL INFUSION PUMPS

2012-04-20

UNOMEDICAL A/S INFUSION DEVICES

I-PORT ADVANCE INJECTION PORT

2012-02-16

UNOMEDICAL A/S

PARADIGM QUICK-SET II AND QUICK-SET II SUBCUTANEOUS INFUSION SETS

2007-04-04

UNOMEDICAL A/S

INTUITION INFUSION SETS

2006-07-31

UNOMEDICAL A/S

COMFORT AND INSET SUBCUTANEOUS INFUSION SETS FOR USE WITH ABBOTT INFUSION PUMPS

2005-09-01

UNOMEDICAL A/S

CONTACT DETACH

2004-06-30

UNOMEDICAL A/S

CLICK-ON

2004-04-01

UNOMEDICAL A/S

UNOMEDICAL MONICA INFUSION SET

2003-10-09

UNOMEDICAL A/S

GUDID

iLet Flex - ilet Flex, 6mm, 46cm 10 pack

Unomedical A/S

2025-12-14

iLet Flex - ilet Flex, 6mm, 60cm 10 pack

Unomedical A/S

2025-12-14

iLet Flex - ilet Flex, 6mm, 80cm 10 pack

Unomedical A/S

2025-12-14

iLet Flex - ilet Flex, 9mm, 46cm 10 pack

Unomedical A/S

2025-12-14

iLet Flex - ilet Flex, 9mm, 60cm 10 pack

Unomedical A/S

2025-12-14

iLet Flex - ilet Flex, 9mm, 80cm 10 pack

Unomedical A/S

2025-12-14

iLet Flex - ilet Flex, 6mm, 46cm 2 pack

Unomedical A/S

2025-12-14

iLet Flex - ilet Flex, 6mm, 60cm 2 pack

Unomedical A/S

2025-12-14

iLet Flex - ilet Flex, 6mm, 80cm 2pack

Unomedical A/S

2025-12-14

iLet Flex - ilet Flex, 9mm, 46cm 2 pack

Unomedical A/S

2025-12-14

iLet Flex - ilet Flex, 9mm, 60cm 2 pack

Unomedical A/S

2025-12-14

iLet Flex - ilet Flex, 9mm, 80cm 2 pack

Unomedical A/S

2025-12-14

Inset II - Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.

Unomedical A/S

2025-11-06

Inset II - Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.

Unomedical A/S

2025-11-06

inset™ - Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.

Unomedical A/S

2024-05-02

inset™ - Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.

Unomedical A/S

2024-05-02

contact detach - Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.

Unomedical A/S

2022-12-21

Autosoft™ XC - Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.

Unomedical A/S

2023-06-13

Autosoft™ XC - Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.

Unomedical A/S

2023-06-13

Autosoft™ XC - Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.

Unomedical A/S

2023-06-13

Medtronic Extended - Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.

Unomedical A/S

2023-06-01

Medtronic Extended - Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.

Unomedical A/S

2023-06-01

Medtronic Extended - Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.

Unomedical A/S

2023-06-01

Medtronic Extended - Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.

Unomedical A/S

2023-06-01

Medtronic Extended - Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.

Unomedical A/S

2023-06-01

Medtronic Extended - Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.

Unomedical A/S

2023-06-01

Medtronic Extended - Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.

Unomedical A/S

2023-06-01

Medtronic Extended - Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.

Unomedical A/S

2023-06-01

Medtronic Extended - Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.

Unomedical A/S

2023-06-01

Medtronic Extended - Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.

Unomedical A/S

2023-06-01

Medtronic Extended - Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.

Unomedical A/S

2023-06-01

Medtronic Extended - Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.

Unomedical A/S

2023-06-01

Medtronic Extended - Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.

Unomedical A/S

2023-06-01

Medtronic Extended - Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.

Unomedical A/S

2023-06-01

Medtronic Extended - Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.

Unomedical A/S

2023-05-24

Medtronic Extended - Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.

Unomedical A/S

2023-05-24

Medtronic Extended - Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.

Unomedical A/S

2022-06-29

Medtronic Extended - Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.

Unomedical A/S

2022-06-29

Medtronic Extended - Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.

Unomedical A/S

2022-06-29

Medtronic Extended - Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.

Unomedical A/S

2022-06-29

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