Unomedical Devices S.A de C.V

Matched from indexed company URL: UNOMEDICAL, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3003442380	3003442380	Unomedical Devices S.A de C.V	1	N	2026-01-01	Avenida Fomento Industrial Lote 9 Manzana 3 Parque Industrial Del Norte Reynosa Tamaulipas MX C.P. 88736
3005778470	3005778470	UNOMEDICAL S.R.O.	1	N	2026-01-01	PRIEMYSELNY 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 GUDID	Product	Phone	Email
05705244027015	iLet Flex - ilet Flex, 9mm, 80cm 10 pack	+18004228811	cic12@convatec.com
05705244027046	iLet Flex - ilet Flex, 6mm, 46cm 2 pack	+18004228811	cic12@convatec.com
05705244027060	iLet Flex - ilet Flex, 6mm, 60cm 2 pack	+18004228811	cic12@convatec.com
05705244027107	iLet Flex - ilet Flex, 6mm, 80cm 2pack	+18004228811	cic12@convatec.com

convatec.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
334712	1081320490	K232665	GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14)	EZD	2024-01-25
334712	1763827780	K213283	GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter	GBM	2022-06-22
334712	1273045649	K181206	GentleCath Glide Intermittent Urinary Catheter	GBM	2018-08-16
9908	1598715279	K132142	NERIA SOFT 90 INFUSION SET	FPA	2013-10-08
9908	1667456802	K120872	ASANTE CONSET AND ASANTE COMFORT SUBCUTANEOUS INFUSION SETS FOR USE WITH ASANTE PEARL INFUSION PUMPS	FPA	2012-04-20
9908	1407896781	K070430	PARADIGM QUICK-SET II AND QUICK-SET II SUBCUTANEOUS INFUSION SETS	FPA	2007-04-04
9908	1924094123	K051264	COMFORT AND INSET SUBCUTANEOUS INFUSION SETS FOR USE WITH ABBOTT INFUSION PUMPS	FPA	2005-09-01
9908	1156702554	K041545	CONTACT DETACH	FPA	2004-06-30
9908	1393100409	K011071	PARADIGM QUICK-SET INFUSION SET	FPA	2001-06-07
9908	1095844366
9908	1104553153
9908	1125014385
9908	1156702554
334712	1192756328
9908	1252821406
9908	1316544487
9908	1530715543
334712	1554131193
9908	1576697062
9908	1598715279
9908	1634770474
334712	1659894410
9908	1687900223
334712	1777559758
9908	1780350920
334712	1816367477
9908	1840849829
9908	1932819209
9908	1939259795
9908	2003148456
9908	2069276138

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
FPA	6	2013-10-08
GBM	2	2022-06-22
EZD	1	2024-01-25

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
NERIA MULTI SUBCUTANEOUS INFUSION SET
2012-05-30
UNOMEDICAL DEVICES S.A DE C.V
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
EUROMEDICAL HAEMATURIA FOLEY CATHETER
1998-09-16
UNOMEDICAL SDN BHD
EUROMEDICAL REINFORCED ENDOTRACHEAL TUBE
1996-11-21
UNOMEDICAL SDN BHD
WIRE REINFORCED SILICONE ENDOTRACHEAL TUBE
1995-12-08
UNOMEDICAL SDN BHD
SILICONE ENDOTRACHEAL TUBE
1995-12-08
UNOMEDICAL SDN BHD
PEDIATRIC WIRE REINFORCED SILICONE ENDOTRACHEAL TUBE
1995-12-08
UNOMEDICAL SDN BHD
PEDIATRIC SILICONE ENDOTRACHEAL TUBE
1995-12-08
UNOMEDICAL SDN BHD
ENDOTRACHEAL TUBE
1995-05-22
UNOMEDICAL SDN BHD
PEDIATRIC ENDOTRACHEAL TUBE
1995-05-22
UNOMEDICAL SDN BHD
SILICATH ALL SILICONE FOLEY CATHETER
1995-03-21
UNOMEDICAL SDN BHD

GUDID#

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
iLet Flex - ilet Flex, 9mm, 60cm 2 pack
Unomedical A/S
2025-12-14
iLet Flex - ilet Flex, 9mm, 46cm 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, 6mm, 60cm 2 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, 9mm, 80cm 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, 46cm 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, 6mm, 60cm 10 pack
Unomedical A/S
2025-12-14
iLet Flex - ilet Flex, 6mm, 46cm 10 pack
Unomedical A/S
2025-12-14
iLet Flex - ilet Flex, 9mm, 80cm 2 pack
Unomedical A/S
2025-12-14
iLet Flex - ilet Flex, 9mm, 46cm 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, 6mm, 60cm 2 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, 9mm, 80cm 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, 46cm 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, 6mm, 60cm 10 pack
Unomedical A/S
2025-12-14
iLet Flex - ilet Flex, 6mm, 46cm 10 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 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
neria™ guard - Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.
Unomedical A/S
2020-01-24
neria™ - Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.
Unomedical A/S
2016-09-15
neria™ guard - Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.
Unomedical A/S
2020-01-24
neria™ guard - Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.
Unomedical A/S
2020-01-24
I-port Advance - Single use injection port for subcutaneous injection. The injection port must be used as described in the Instruction for Use.
Unomedical A/S
2016-09-15
I-port Advance - Single use injection port for subcutaneous injection. The injection port must be used as described in the Instruction for Use.
Unomedical A/S
2016-09-15
neria multi - Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.
Unomedical A/S
2016-09-15
neria multi - Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.
Unomedical A/S
2016-09-15
Mio® - Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.
Unomedical A/S
2016-09-15
neria multi - Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.
Unomedical A/S
2016-09-15
neria multi - Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.
Unomedical A/S
2016-09-15
neria™ - Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.
Unomedical A/S
2016-09-15

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