Terumo Europe N V

FDA Filings

This page includes the latest FDA filings for Terumo Europe N V. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number9681413
FEI Number3001570557
NameTERUMO EUROPE N.V.
Owner & OperatorTerumo Europe N.V.
Contact AddressInterleuvenlaan 40
Leuven BE-VBR Vlaams Brabant 3001 BE
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressINTERLEUVENLAAN 40
LEUVEN Vlaams Brabant, 3001 BE
Establishment Type
  • Manufacture Medical Device
  • Export Device to the United States But Perform No Other Operation on Device

FDA Filings

Device
Company
DeviceDate
Terumo Europe NV
 Terumo NF-3013RBKE05M2023-11-06
Terumo Europe NV
 Surguard®3 SG3-2516RB2022-11-07
Terumo Europe NV
 Surguard®3 SG3-2138RB2022-11-07
Terumo Europe NV
 Surguard®3 SG3-1938RB2022-11-07
Terumo Europe NV
 Surguard®3 SG3-1925RB2022-11-07
Terumo Europe N.V.
SurGuard3 Safety Hypodermic Needle2022-08-22
Terumo Europe NV
 K-Pack II KN-2713RBK2022-04-13
Terumo Europe NV
 K-Pack II Needle KN-2719RBT500P2020-12-23
Terumo Europe NV
 K-Pack II KN-2713RB500P2020-10-06
Terumo Europe NV
 SURFLO® SV-S25WL35C2020-09-08
Terumo Europe NV
 K-Pack II KN-3013RBKU2019-11-22
Terumo Europe NV
 K-Pack II KN-3013RBKE2019-11-22
Terumo Europe NV
 K-Pack II KN-2713RBKTU2019-11-22
Terumo Europe NV
 K-Pack II KN-2713RBKTE2019-11-22
Terumo Europe NV
 K-Pack II KN-3013RKT502019-10-23
Terumo Europe NV
 K-Pack II KN-2713RKT502019-10-23
Terumo Europe NV
 K-Pack II KN-2719RB500P2019-10-23
Terumo Europe NV
 K-Pack II KN-2038RB500P2019-10-23
Terumo Europe NV
 K-Pack II KN-2713RBKT502019-10-23
Terumo Europe NV
 K-Pack II KN-2232RBB2019-10-23
Terumo Europe NV
 K-Pack II KN-2150RB2019-10-23
Terumo Europe NV
 K-Pack II KN-2038RB2019-10-23
Terumo Europe NV
 K-Pack II KN-2719RB2019-10-23
Terumo Europe NV
 K-Pack II KN-2719RBT2019-10-23
Terumo Europe NV
 K-Pack II KN-2616RB2019-10-23
Terumo Europe NV
 K-Pack II KN-3013RBKT2019-10-23
Terumo Europe NV
 K-Pack II KN-2713RBKT2019-10-23
Terumo Europe NV
 K-Pack Surshield™ KN-S2713RB2019-10-23
Terumo Europe NV
 K-Pack Surshield™ KN-S2516RB2019-10-23
Terumo Europe NV
 K-Pack II KN-2913RBKT2019-10-23
Terumo Europe NV
 K-Pack II KN-2913RBS2019-10-23
Terumo Europe NV
 K-Pack II KN-2913RB2019-10-23
Terumo Europe NV
 K-Pack II KN-2516RB052019-10-23
Terumo Europe NV
 K-Pack II KN-2138RB042019-10-23
Terumo Europe NV
 K-Pack II KN-2325RB042019-10-23
Terumo Europe NV
 K-Pack II KN-2525RB042019-10-23
Terumo Europe NV
 K-Pack II KN-1838SBS2019-10-23
Terumo Europe NV
 K-Pack II KN-1938RB2019-10-23
Terumo Europe NV
 K-Pack II KN-2238RB2019-10-23
Terumo Europe NV
 K-Pack II KN-2713RBR2019-10-23
Terumo Europe NV
 K-Pack II KN-2713RB2019-10-23
Terumo Europe NV
 K-Pack II KN-2138RB2019-10-23
Terumo Europe NV
 K-Pack II KN-2525RB2019-10-23
Terumo Europe NV
 K-Pack II KN-2516RB042019-10-23
Terumo Europe NV
 K-Pack II KN-2325RB2019-10-23
Terumo Europe NV
 K-Pack II KN-1838SB2019-10-23
Terumo Europe NV
 K-Pack II KN-2719RBTS2019-10-23
Terumo Europe NV
 K-Pack II KN-2908RBKT2019-10-23
Terumo Europe NV
 K-Pack II KN-3013RB2019-10-23
Terumo Europe NV
 K-Pack II KN-2232RB2019-10-23
Terumo Europe NV
 K-Pack II KN-2610RB2019-10-23
Terumo Europe NV
 K-Pack II KN-2332RB2019-10-23
TERUMO EUROPE N.V.
K-Pack II Needles 27G x 1/2? Extra Thin Wall2019-10-16
TERUMO EUROPE N.V.
K-Pack II Needle - 30G x 1/2" Ultra Thin Wall2019-10-16
TERUMO EUROPE N.V.
K-Pack II Needle - 30G x 1/2" Extra Thin Wall2019-10-16
TERUMO EUROPE N.V.
K-Pack II Needle - 27G x 1/2" Ultra Thin Wall2019-10-16
TERUMO EUROPE N.V.
Terumo SurGuard?3 Safety Hypodermic Needle2019-10-16
TERUMO EUROPE N.V.
Terumo SurGuard?3 Safety Hypodermic Needle & Terumo SurGuard?3 Hypodermic Syringe with Safety Needle2019-10-16
TERUMO EUROPE N.V.
Terumo SurGuard?3 Safety Hypodermic Needle & Terumo SurGuard?3 Hypodermic Syringe with Safety Needle2019-10-16
Terumo Europe N.V.
K-Pack II Needle - 27G X 1/2” Extra Thin Wall, K-Pack II Needle - 27G X 1/2” Ultra Thin Wall, K-Pack II Needle - 30G X 1/2” Extra Thin Wall, K-Pack II Needle - 30G X 1/2” Ultra Thin Wall2019-10-11
TERUMO EUROPE N.V.
Neolus Needle2018-12-21
Terumo Europe NV
 Syringe with fixed needle - For use only with GONA BS-N1A2713U2018-07-06
Terumo Europe NV
 SURFLO® SV-S25FL35C2018-07-06
Terumo Europe NV
 Syringe with fixed needle - For use only with GONA BS-N1A2713U102018-07-06
Terumo Europe NV
 Syringe with fixed needle - For use only with GONA BS-N1A2713U62018-07-06
Terumo Europe NV
 SURFLO® SV-S25WL352018-07-06
Terumo Europe NV
 SURFLO® SV-S23WL352018-07-06
Terumo Europe NV
 SURFLO® SV-S25FL352018-07-06
Terumo Europe NV
 SURFLO® SV-S23FL352018-07-06
Terumo Europe NV
 SURFLO® SV-S25BL352018-07-06
Terumo Europe NV
 SURFLO® SV-S23BL352018-07-06
TERUMO EUROPE N.V.
CAPIOX FX15 and FX25 Hollow Fiber Oxygenators/Reservoirs with Integrated Arterial Filter (with X-Coating)2017-05-17
TERUMO EUROPE N.V.
Syringe with fixed needle - For use only with GONAL-f Multi-Dose 600IU/mL FSH2017-02-22
TERUMO EUROPE N.V.
Syringe with fixed needle - For use only with GONAL-f Multi-Dose 600IU/mL FSH2017-02-22
TERUMO EUROPE N.V.
Syringe With Fixed Needle - For Use Only With GONAL-F Multi-Dose 600 I/U ML FSH2017-02-10
TERUMO EUROPE N.V.
K-Pack II Needle - 29Gx5/16" Thin Wall2015-07-06
TERUMO EUROPE N.V.
K-Pack II Needle - 29G X 5/16 Thin Wall2015-06-25
TERUMO EUROPE N.V.
K-Pack II Needle - 21G x 22015-04-09
TERUMO EUROPE N.V.
K-Pack II Needle-21G X 22015-04-01
TERUMO EUROPE N.V.
SURFLO? Winged Infusion Set With Filter and Needle Protection (Surshield?)2014-03-20
TERUMO EUROPE N.V.
SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (SURSHIELD)2014-03-18
TERUMO EUROPE N.V.
Surflo Winged Infusion Set With Needle Protection (Surshield)2014-02-10
TERUMO EUROPE N.V.
SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD)2014-02-05
TERUMO EUROPE N.V.
K-Pack II Needle 27Gx3/4 Thin Wall2013-09-16
TERUMO EUROPE N.V.
K-PACK II NEEDLE - 27G X 3/4 THIN WALL2013-09-06
TERUMO EUROPE N.V.
with Safety Needle, Surguard 3 Safety Needle, Surguard 3 Safety Syringe2013-01-14
TERUMO EUROPE N.V.
Terumo SurGuard3 Safety Needle and Terumo SurGuard3 Hypodermic Syringe2013-01-14
TERUMO EUROPE N.V.
with Safety Needle, Surguard 3 Safety Needle, Surguard 3 Safety Syringe2013-01-14
TERUMO EUROPE N.V.
Terumo SurGuard3 Safety Needle and Terumo SurGuard3 Hypodermic Syringe2013-01-14
TERUMO EUROPE N.V.
27G X 1/22011-10-10
TERUMO EUROPE N.V.
27 G X 1/2 K-PACK SURSHIELD NEEDLE2011-09-22
TERUMO EUROPE N.V.
K-Pack II Needle 27G & 30G Thin Wall2011-06-24
TERUMO EUROPE N.V.
K-Pack Surshield Needle,2011-06-24
TERUMO EUROPE N.V.
Hypodermic Needle for Single Use2011-06-24
TERUMO EUROPE N.V.
K-PACK II NEEDLE- 27G & 30G THIN WALL2011-06-09
TERUMO EUROPE N.V.
K-PACK SURSHIELD NEEDLE, HYPODERMIC NEEDLE FOR SINGLE USE2011-06-06
TERUMO EUROPE N.V.
Integrated Arterial Filter2010-11-19
TERUMO EUROPE N.V.
Capiox FX Hollow Fiber Oxygenator with2010-11-19
TERUMO EUROPE N.V.
K-Pack II2010-11-04
TERUMO EUROPE N.V.
Surflo Winged Infusion Set with Needle Protection (Surshield)2010-11-04
TERUMO EUROPE N.V.
K-Pack II Needle - 29G Thin Wall2010-11-04
TERUMO EUROPE N.V.
Surflo Winged Infusion Set2010-11-04
TERUMO EUROPE N.V.
K-Pack II 29G2010-11-04
TERUMO EUROPE N.V.
Terumo Surguard2 Safety Needle2010-11-04
TERUMO EUROPE N.V.
Terumo Syringe2010-11-04
TERUMO EUROPE N.V.
INTRAVSCULAR ADMINISTRATION SET2010-08-02
TERUMO EUROPE N.V.
K-PACK II NEEDLE - 29G THIN WALL2008-10-23
TERUMO EUROPE N.V.
SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD)2007-11-06
TERUMO EUROPE N.V.
50 ML TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES, MODEL BS-50LB2007-05-29
TERUMO EUROPE N.V.
SURFLO WINGED INFUSION SET WITH FILTER AND NEEDLE PROTECTION (SURSHIELD)2007-05-25
TERUMO EUROPE N.V.
SURFLO WINGED INFUSION SET2007-05-07
TERUMO EUROPE N.V.
29G AND 30G K-PACK II NEEDLE2006-09-15
TERUMO EUROPE N.V.
TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES2006-04-06
TERUMO EUROPE N.V.
SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD), MODEL SV-S23BL35VS2005-12-08
TERUMO EUROPE N.V.
VENOJECT LUER ADAPTER2004-05-28
TERUMO EUROPE N.V.
NEOLUS NEEDLE2000-08-14
TERUMO EUROPE N.V.
K-PACK II (HYPODERMIC NEEDLE) 23G X 1, MODEL KN-2325RB, K-PACK II NEEDLE (HYPODERMIC NEEDLE) 25G X 1, MODEL KN-2525RB, K1999-06-14

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020090540764Sines,Portugal -> Long Beach, CaliforniaWING INFUSION SET AND K-PACK NEEDLE518 CTN
2020090450677Sines,Portugal -> Long Beach, CaliforniaWING INFUSION SET AND K-PACK NEEDLE518 CTN
2020061016537Anvers,Belgium -> New Orleans, LouisianaWINGED INFUSION SET WITH NEEDLE PROTECTION445 PKG
2020061016537Anvers,Belgium -> New Orleans, LouisianaWINGED INFUSION SET WITH NEEDLE PROTECTION445 PKG
2020061016537Anvers,Belgium -> New Orleans, LouisianaWINGED INFUSION SET WITH NEEDLE PROTECTION445 PKG
2020040931569Anvers,Belgium -> Charleston, South Carolina------------ TCNU3138940 DESCRIPTION--------- 14 PACKAGES KN-2138RB - KN-2232RBB - MEDICAL SUPPLIES - HS CODE 9018321000 -------------GENERIC DESCRIPTION------------- FREIGHT PREPAID14 PCS
202003048514Anvers,Belgium -> Los Angeles, CaliforniaSTC MEDICAL ITEMS AS PER SHIPPER'S INVOICE 97855921 + 97860959 HS CODE: 90183210488 PKG
202003048514Anvers,Belgium -> Los Angeles, CaliforniaSTC MEDICAL ITEMS AS PER SHIPPER'S INVOICE 97855921 + 97860959 HS CODE: 90183210488 PKG
2019102817186Anvers,Belgium -> Los Angeles, CaliforniaSTC MEDICAL ITEMS AS PER SHIPPER'S INVOICE 97502963+97503300+97498307+ 97503002 HS CODE: 901832635 PKG
2019071526892Rotterdam,Netherlands -> Norfolk, VirginiaSLAC 229 CARTONS MEDICAL INSTRUMENTS INVOI CE NO 97133999 - 97131735 NET WEIGHT 926.89 K3 PCS
2018122736990Anvers,Belgium -> New York/Newark Area, Newark, New JerseyMEDICAL SUPPLIES HS CODE 90183210492 CTN
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