Redax S P A

FDA Filings

This page includes the latest FDA filings for Redax S P A. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3013058659
• FEI Number: 3013058659
• Name: REDAX S.P.A
• Owner & Operator: Redax S.p.A
• Contact Address: Via Galileo Galilei 18 ; Poggio Rusco IT-MN Mantova 46025 IT
• Official Correspondent:
  • Andrea Gibertoni
  • 39-038-6830582-x
• US Agent:
  • Korina Akhondzadeh
  • KARA & Associates
  • 858 3448168
  • korina@kara2a.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Via Galileo Galilei 18 ; Poggio Rusco Mantova, 46025 IT
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 18034139297030 REDAX SPA	Connector for silicone Fr 19 10551	2021-05-19
GUDID 18034139297023 REDAX SPA	Connector for silicone Fr 15 10549	2021-05-19
GUDID 18034139297016 REDAX SPA	Connector for silicone Fr 10-12 10523	2021-05-19
GUDID 18034139296644 REDAX SPA	Y connector 3/8 for silicone Fr 16 10528	2021-05-19
GUDID 18034139296606 REDAX SPA	Connector for silicone Fr 24 10526	2021-05-19
GUDID 18034139295494 REDAX SPA	Y connector 1/4 Fr 18-24 10513	2021-05-19
GUDID 18034139291120 REDAX SPA	Connector for Spiral Drain Fr 15-19 10527	2021-05-19
GUDID 18034139291045 REDAX SPA	Y connector 3/8 Fr 15-20 10518	2021-05-19
GUDID 18034139291021 REDAX SPA	Y connector 1/4 1/4 1/4 Fr 24-32 10516	2021-05-19
GUDID 18034139291014 REDAX SPA	Y connector 3/8 1/4 1/4 Fr 24-32 10515	2021-05-19
GUDID 18034139290970 REDAX SPA	Connector for drainage Fr 32-40 10509	2021-05-19
GUDID 08034139290980 REDAX SPA	Y connector 3/8 Fr 36-40 10510	2021-05-19
GUDID 08034139290959 REDAX SPA	Universal connector 1/4 x 1/4 Fr 24-36 10507	2021-05-19
GUDID 18034139297306 REDAX SPA	Smart Drain Round Coaxial Drain Fr 28 24730	2021-05-17
GUDID 18034139296682 REDAX SPA	Smart Drain Round Coaxial Drain Fr 28 24729	2021-05-17
GUDID 18034139296675 REDAX SPA	Smart Drain Round Coaxial Drain Fr 24 24727	2021-05-17
GUDID 18034139296590 REDAX SPA	Smart Drain Round Fluted Drain w/bendable trocar Fr 12 24905	2021-05-17
GUDID 18034139296583 REDAX SPA	Smart Drain Round Fluted Drain w/bendable trocar Fr 19 24904	2021-05-17
GUDID 18034139296576 REDAX SPA	Smart Drain Round Fluted Drain w/bendable trocar Fr 15 24903	2021-05-17
GUDID 18034139296569 REDAX SPA	Smart Drain Round Fluted Drain w/bendable trocar Fr 10 24902	2021-05-17
GUDID 18034139296514 REDAX SPA	Smart Drain Round Coaxial Drain Fr 24 24725	2021-05-17
GUDID 18034139296491 REDAX SPA	Smart Drain Round Coaxial Drain Fr 28 24726	2021-05-17
GUDID 18034139296460 REDAX SPA	Smart Drain Round Fluted Drain Fr 32 24732	2021-05-17
GUDID 18034139295975 REDAX SPA	Smart Drain Round Fluted Drain Fr 24 24724	2021-05-17
GUDID 18034139295869 REDAX SPA	Kardia Spiral Round Fluted Drain Fr 24 25024	2021-05-17
GUDID 18034139295852 REDAX SPA	Kardia Spiral Round Fluted Drain Fr 19 25019	2021-05-17
GUDID 18034139295197 REDAX SPA	Smart Drain Round Fluted Drain Fr 15 24715	2021-05-17
GUDID 18034139295180 REDAX SPA	Smart Drain Round Fluted Drain Fr 7 24712	2021-05-17
GUDID 18034139295173 REDAX SPA	Smart Drain Round Fluted Drain Fr 10 24710	2021-05-17
GUDID 18034139295135 REDAX SPA	Smart Drain Round Fluted Drain w/trocar Fr 10 24702	2021-05-17
GUDID 18034139295098 REDAX SPA	Flat Fluted Drain w/trocar 3x7 mm 24625	2021-05-17
GUDID 18034139295067 REDAX SPA	Flat Fluted Drain 4x10 mm 24622	2021-05-17
GUDID 18034139295050 REDAX SPA	Spiral Drain Round Fluted Drain Fr 24 24621	2021-05-17
GUDID 18034139295036 REDAX SPA	Spiral Drain Round Fluted Drain Fr 19 24619	2021-05-17
GUDID 18034139295029 REDAX SPA	Spiral Drain Round Fluted Drain Fr 15 24615	2021-05-17
GUDID 18034139295005 REDAX SPA	Spiral Drain Round Fluted Drain Fr 10 24610	2021-05-17
GUDID 18034139294978 REDAX SPA	Spiral Drain Round Fluted Drain Fr 7 24607	2021-05-17
GUDID 18034139294961 REDAX SPA	Spiral Drain Round Fluted Drain w/trocar Fr 12 24605	2021-05-17
GUDID 18034139294947 REDAX SPA	Spiral Drain Round Fluted Drain w/trocar Fr 15 24603	2021-05-17
GUDID 18034139294930 REDAX SPA	Spiral Drain Round Fluted Drain w/trocar Fr 10 24602	2021-05-17
GUDID 18034139294695 REDAX SPA	Round Drain type Jackson-Pratt w/trocar Fr 15 24221	2021-05-17
GUDID 18034139294657 REDAX SPA	Round Drain type Jackson-Pratt w/trocar Fr 10 24211	2021-05-17
GUDID 18034139294640 REDAX SPA	Round Drain type Jackson-Pratt Fr 10 24210	2021-05-17
GUDID 18034139294626 REDAX SPA	Round Drain type Jackson-Pratt Fr 7 24200	2021-05-17
GUDID 18034139294596 REDAX SPA	Flat Drain type Jackson-Pratt w/trocar 4x13 mm 24141	2021-05-17
GUDID 18034139294589 REDAX SPA	Flat Drain type Jackson-Pratt 4x13 mm 24140	2021-05-17
GUDID 18034139294572 REDAX SPA	Flat Drain type Jackson-Pratt w/trocar 4x10 mm 24131	2021-05-17
GUDID 18034139294565 REDAX SPA	Flat Drain type Jackson-Pratt 4x10 mm 24130	2021-05-17
GUDID 18034139294541 REDAX SPA	Flat Drain 3/4 type Jackson-Pratt 4x10 mm 24120	2021-05-17
GUDID 18034139293810 REDAX SPA	Thoracic Catheter, Angled Fr 33 21833	2021-05-17
GUDID 18034139293803 REDAX SPA	Thoracic Catheter, Angled Fr 30 21830	2021-05-17
GUDID 18034139292875 REDAX SPA	Thoracic Catheter, Straight Fr 33 20833	2021-05-17
GUDID 18034139292868 REDAX SPA	Thoracic Catheter, Straight Fr 30 20830	2021-05-17
GUDID 18034139292844 REDAX SPA	Thoracic Catheter, Straight Fr 24 20824	2021-05-17
GUDID 18034139292837 REDAX SPA	Thoracic Catheter, Straight Fr 21 20821	2021-05-17
GUDID 18034139292820 REDAX SPA	Thoracic Catheter, Straight Fr 18 20818	2021-05-17
GUDID 18034139296453 REDAX SPA	Smart Drain Round Fluted Drain Fr 28 24728	2021-05-13
GUDID 18034139295203 REDAX SPA	Smart Drain Round Fluted Drain Fr 19 24719	2021-05-13
GUDID 18034139295166 REDAX SPA	Smart Drain Round Fluted Drain Fr 12 w/trocar 24705	2021-05-13
GUDID 18034139295159 REDAX SPA	Smart Drain Round Fluted Drain Fr 19 w/trocar 24704	2021-05-13
GUDID 18034139295081 REDAX SPA	Flat Fluted Drain 4x10 mm w/trocar 24623	2021-05-13
GUDID 18034139295012 REDAX SPA	Spiral Drain Round Fluted Drain Fr 12 24612	2021-05-13
GUDID 18034139294954 REDAX SPA	Spiral Drain Round Fluted Drain Fr 19 w/trocar 24604	2021-05-13
GUDID 18034139294718 REDAX SPA	Round Drain type Jackson-Pratt Fr 19 w/trocar 24231	2021-05-13
GUDID 18034139294701 REDAX SPA	Round Drain type Jackson-Pratt Fr 19 24230	2021-05-13
GUDID 18034139294633 REDAX SPA	Round Drain type Jackson-Pratt Fr 7 w/trocar 24201	2021-05-13
GUDID 18034139294558 REDAX SPA	Flat Drain 3/4 type Jackson-Pratt 4x10 mm w/trocar 24121	2021-05-13
GUDID 18034139294534 REDAX SPA	Flat Drain type Jackson-Pratt 3x7 mm w/trocar 24111	2021-05-13
GUDID 18034139294527 REDAX SPA	Flat Drain type Jackson-Pratt 3x7 mm 24110	2021-05-13
GUDID 18034139294510 REDAX SPA	Flat Drain 3/4 type Jackson-Pratt 3x7 mm w/trocar 24101	2021-05-13
GUDID 18034139293827 REDAX SPA	Thoracic Catheter, Angled Fr 36 21836	2021-05-13
GUDID 18034139293797 REDAX SPA	Thoracic Catheter, Angled Fr 28 21828	2021-05-13
GUDID 18034139293780 REDAX SPA	Thoracic Catheter, Angled Fr 24 21824	2021-05-13
GUDID 18034139292882 REDAX SPA	Thoracic Catheter, Straight Fr 36 20836	2021-05-13
GUDID 18034139292851 REDAX SPA	Thoracic Catheter, Straight Fr 28 20828	2021-05-13
GUDID 18034139292813 REDAX SPA	Thoracic Catheter, Straight Fr 15 20815	2021-05-13
GUDID 08034139294681 REDAX SPA	Round Drain type Jackson-Pratt Fr 15 24220	2021-05-13
GUDID 18034139297115 REDAX SPA	Drentech Pump 100 ml Flat Drainage 3/4 w/trocar 4x10 mm 10458	2021-05-12
GUDID 18034139297108 REDAX SPA	Drentech Pump 100 ml Flat Drainage 3/4 w/trocar 3x7 mm 10457	2021-05-12
GUDID 18034139297092 REDAX SPA	Drentech Pump 100 ml Round Drainage w/trocar Fr 10 10464	2021-05-12
GUDID 18034139295142 REDAX SPA	Smart Drain Round Fluted Drain Fr 15 24703	2021-05-12
GUDID 18034139295074 REDAX SPA	Flat Fluted Drain 3x7 mm 24623	2021-05-12
GUDID 18034139294923 REDAX SPA	Spiral Drain Round Fluted Drain Fr 7 24601	2021-05-12
GUDID 18034139294053 REDAX SPA	Drentech Closed Silicone Reservoir 200 ml 22620	2021-05-12
GUDID 18034139294008 REDAX SPA	Drentech Closed Silicone Reservoir 100 ml 22610	2021-05-12
GUDID 18034139293971 REDAX SPA	Drentech Closed Silicone Reservoir 400 ml 22600	2021-05-12
GUDID 18034139292806 REDAX SPA	Thoracic Catheter, Straight Fr 12 20812	2021-05-12
GUDID 18034139291687 REDAX SPA	Drentech Bag - Replacement 12015	2021-05-12
GUDID 18034139291670 REDAX SPA	Drentech Bag - Replacement 12014	2021-05-12
GUDID 18034139291595 REDAX SPA	Drentech Bag - Replacement 12004	2021-05-12
GUDID 18034139290871 REDAX SPA	Drentech Pump 100 ml Round Drainage w/trocar Fr 15 10483	2021-05-12
GUDID 18034139290840 REDAX SPA	Drentech Pump 400 ml Round Drainage w/trocar Fr 19 10463	2021-05-12
GUDID 18034139290819 REDAX SPA	Drentech Pump 100 ml Flat Drainage w/trocar 4x10 mm 10456	2021-05-12
GUDID 18034139290802 REDAX SPA	Drentech Pump 100 ml Flat Drainage 3x7 mm w/trocar 10455	2021-05-12
GUDID 18034139290642 REDAX SPA	Silicone Reservoir 400 ml 10420	2021-05-12
GUDID 18034139290635 REDAX SPA	Silicone Reservoir 200 ml 10410	2021-05-12
GUDID 18034139290611 REDAX SPA	Drentech Pump 100 ml Flat Drainage 4x10 mm 10404	2021-05-12
GUDID 18034139290604 REDAX SPA	Drentech Pump 100 ml Flat Drainage 4x10 mm 10403	2021-05-12
GUDID 18034139290598 REDAX SPA	Drentech Pump 100 ml Flat Drainage 3x7 mm 10402	2021-05-12
GUDID 08034139294094 REDAX SPA	Drentech Closed Silicone Reservoir 200 ml 22630	2021-05-12
KDQ REDAX S.P.A	Heimlich Valve	2020-02-28
KGZ REDAX S.P.A	REDAX ? Connectors	2016-06-10
GCY REDAX S.P.A	Spiral Drain ? Round Fluted Drain	2016-06-10
GCY REDAX S.P.A	Smart Drain Round Fluted Drain	2016-06-10
GCY REDAX S.P.A	Smart Drain Round Coaxial Drain	2016-06-10
GCY REDAX S.P.A	Silicone Reservoir Kit	2016-06-10
GCY REDAX S.P.A	Round Drain type Jackson-Pratt ?	2016-06-10
GCY REDAX S.P.A	Penrose Type Drain	2016-06-10
GCY REDAX S.P.A	Kardia Spiral Round Fluted Drain	2016-06-10
GCY REDAX S.P.A	Flat Fluted Drain	2016-06-10
GCY REDAX S.P.A	Flat Drain type Jackson-Pratt ?	2016-06-10
GCY REDAX S.P.A	DRENTECH PUMP Silicone Reservoir	2016-06-10
GCY REDAX S.P.A	DRENTECH CLOSED Silicone Reservoir	2016-06-10
GCY REDAX S.P.A	DRENTECH BAG - Replacement	2016-06-10
GBX REDAX S.P.A	Thoracic Catheter, Straight	2016-06-10
GBX REDAX S.P.A	Thoracic Catheter, Angled	2016-06-10

Related Finance Registrations

NCAGE Code	AP848	REDAX SPA
CAGE Code	AP848	REDAX SPA

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020061575000	La Spezia,Italy -> Miami, Florida	INSTRUMENTS AND APPLIANCES USED IN MEDICAL, S URGIC - DRENTECH COMPACT HS CODE: 90189084	1656 PKG
2020052339313	La Spezia,Italy -> Miami, Florida	INSTRUMENTS AND APPLIANCES USED IN MEDICAL, S URGIC - (PALLET) DRENTECH COMPACT	19 BOX
2020032832917	La Spezia,Italy -> Miami, Florida	DRENTECH COMPACT - DRENTECH COMPACT	23 PKG
2020030930979	La Spezia,Italy -> Miami, Florida	INSTRUMENTS AND APPLIANCES USED IN MEDICAL, S URGIC - DRENTECH COMPACT HS CODE: 90189084	23 BOX
2020010741307	La Spezia,Italy -> Miami, Florida	INSTRUMENTS AND APPLIANCES USED IN MEDICAL, S URGIC - DRENTECH COMPACT PLUS LITHIUM BATTERY SPECIAL PROVISION 188	24 PKG
2019111840979	La Spezia,Italy -> Miami, Florida	INSTRUMENTS AND APPLIANCES USED IN MEDICAL, S URGIC - DRENTECH COMPACT; DRENTECH MOBILE	24 PKG
2019102153685	La Spezia,Italy -> Miami, Florida	INSTRUMENTS AND APPLIANCES USED IN MEDICAL, S URGIC - DRENTECH COMPACT HS CODE: 90189084	11 PKG
2019100836193	La Spezia,Italy -> Miami, Florida	DRENTECH COMPACT PLUS LITHIUM BATTERY SPECIAL PROV - DRENTECH COMPACT PLUS LITHIUM BATTERY SPECIAL PROVISION 188 HS CODE: 90189084	13 PKG