David Rothkopf

FDA Filings

This page includes the latest FDA filings for David Rothkopf. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3003908754
FEI Number3003908754
Namedavid Rothkopf
Owner & OperatorThe Helping Hand Company
Contact AddressBromyard Rd
Ledbury GB-HEF Herefordshire, County of 01531 6356 GB
Official Correspondent
  • Andrew Wilson
  • 44-153-1635670-x
US Agent
Importing Logistics Registration
ImporterNancy Bannon c/o Tobin, Ginsalves & Woods
AddressSuite 6 331 Page St
Stoughton, MA 02072 UNITED STATES
Phone1 781 3441227
Importer TypeAGENT
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address200 Homer Ave
Ashland, MA 01721 US
Establishment TypeManufacture Medical Device

Registration Number3010877292
FEI Number3010877292
NameDavid Rothkopf
Owner & OperatorPharma Systems Eesti OU
Contact AddressEmmaste
Emmaste vald EE-39 Hiiumaa 92001 EE
Official Correspondent
  • Viljar Salumaa
  • 372-46-22460-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address200 Homer Ave
Ashland, MA 01721 US
Establishment TypeManufacture Medical Device

Registration Number3005519819
FEI Number3005519819
NameDavid Rothkopf
Owner & OperatorPharma Systems AB
Contact AddressRubanksgatan 9
Knivsta SE-C Uppsala lan [SE-03] 74171 SE
Official Correspondent
  • Viljar Salumaa
  • 46-18-349500-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address200 Homer Ave
Ashland, MA 01721 US
Establishment TypeManufacture Medical Device

Registration Number3005940400
FEI Number3005940400
NameDavid Rothkopf
Owner & Operator3Shape A/S
Contact AddressHolmens Kanal 7
Copenhagen K DK-84 Region Hovedstaden 1060 DK
Official Correspondent
  • David Rothkopf
  • 045-70-272620-x
US Agent
Importing Logistics Registration
Importer3Shape Inc.
Address571 Central Ave Suite 109
New Providence, NJ 07974 UNITED STATES
Importer Typesales office
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address200 Homer Ave
Ashland, MA 01721 US
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device

Registration Number3009685834
FEI Number3009685834
NameDavid Rothkopf
Owner & OperatorSakura Seiki Co., Ltd Chikuma factory
Contact Address46-1 Shinden
chikuma JP-20 Nagano 387-0018 JP
Official Correspondent
  • Yashi Osaka
  • 81-06-69108824-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address200 Homer Ave
Ashland, MA 01721 US
Establishment TypeManufacture Medical Device

Registration Number3015172511
FEI Number3015172511
NameDavid Rothkopf
Owner & Operator3Shape A/S
Contact AddressHolmens Kanal 7
Copenhagen K DK-84 Region Hovedstaden 1060 DK
Official Correspondent
  • David Rothkopf
  • 045-70-272620-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address200 Homer Ave
Ashland, MA 01721 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device
Company
DeviceDate
David Rothkopf [3Shape A/S]
3Shape Splint Design2020-01-23
David Rothkopf [3Shape A/S]
Ortho System2019-12-31
David Rothkopf [3Shape A/S]
3Shape Ortho System Mouthguard2019-12-31
David Rothkopf [Sakura Seiki Co., Ltd Chikuma factory]
Skytron Integrity 270P Steam Sterilizer2019-12-04
David Rothkopf [Sakura Seiki Co., Ltd Chikuma factory]
Skytron Integrity 270 Steam Sterilizer2019-12-04
David Rothkopf [Sakura Seiki Co., Ltd Chikuma factory]
Skytron Integrity 215SG Steam Sterilizer2019-12-04
David Rothkopf [Sakura Seiki Co., Ltd Chikuma factory]
Skytron Integrity 175SG Steam Sterilizer2019-12-04
David Rothkopf [Sakura Seiki Co., Ltd Chikuma factory]
Skytron Integrity 175 Steam Sterilizer2019-12-04
David Rothkopf [Sakura Seiki Co., Ltd Chikuma factory]
Sky torn Integrity 215 Steam Sterilizer2019-12-04
David Rothkopf [Sakura Seiki Co., Ltd Chikuma factory]
Sakura Steam Sterilizer ASSV-AH06E2019-12-04
David Rothkopf [Sakura Seiki Co., Ltd Chikuma factory]
Sakura Steam Sterilizer ASSV-AH062019-12-04
David Rothkopf [Sakura Seiki Co., Ltd Chikuma factory]
Sakura Steam Sterilizer ASSV-AB09E2019-12-04
David Rothkopf [Sakura Seiki Co., Ltd Chikuma factory]
Sakura Steam Sterilizer ASSV-AB092019-12-04
David Rothkopf [Sakura Seiki Co., Ltd Chikuma factory]
Sakura Steam Sterilizer ASSR-AO12W2019-12-04
David Rothkopf [Sakura Seiki Co., Ltd Chikuma factory]
Sakura Steam Sterilizer ASSR-AO12PW2019-12-04
David Rothkopf [Sakura Seiki Co., Ltd Chikuma factory]
Sakura Steam Sterilizer ASSR-AO12P2019-12-04
David Rothkopf [Sakura Seiki Co., Ltd Chikuma factory]
Sakura Steam Sterilizer ASSR-AO122019-12-04
David Rothkopf [3Shape A/S]
Ortho System2018-01-24
David Rothkopf [3Shape A/S]
Abutment designer2017-12-01
David Rothkopf [3Shape A/S]
3Shape Ortho System2016-08-30
David Rothkopf [3Shape A/S]
3Shape Ortho System2016-08-30
David Rothkopf [Pharma Systems Eesti OU]
ThermoFlo Neo2014-12-22
David Rothkopf [Pharma Systems Eesti OU]
ThermoFlo Neo Port2014-12-22
David Rothkopf [Pharma Systems Eesti OU]
oxygen adapter2014-12-22
David Rothkopf [Pharma Systems Eesti OU]
ThermoFlo Midi2014-12-22
David Rothkopf [Pharma Systems Eesti OU]
ThermoFlo Filter2014-12-22
David Rothkopf [Pharma Systems Eesti OU]
ThermoFlo Filter Port2014-12-22
David Rothkopf [Pharma Systems Eesti OU]
ThermoFlo Filter PhFlex2014-12-22
David Rothkopf [Pharma Systems Eesti OU]
ThermoFlo Filter Midi2014-12-22
David Rothkopf [Pharma Systems Eesti OU]
ThermoFlo Filter HCH2014-12-22
David Rothkopf [Pharma Systems Eesti OU]
ThermoFlo 1 Filter2014-12-22
David Rothkopf [Pharma Systems Eesti OU]
ThermoFlo 1 Filter Port2014-12-22
David Rothkopf [Pharma Systems Eesti OU]
ThermoFlo 1 Filter Port Elbow2014-12-22
David Rothkopf [Pharma Systems Eesti OU]
ThermoFlo 1 Filter Port Angle2014-12-22
David Rothkopf [Pharma Systems Eesti OU]
Pharma Trach Multi2014-12-22
David Rothkopf [Pharma Systems Eesti OU]
Pharma Trach Basic2014-12-22
David Rothkopf [Pharma Systems Eesti OU]
Pharma Suction2014-12-22
David Rothkopf [Pharma Systems Eesti OU]
ThermoFlo2014-12-22
David Rothkopf [Pharma Systems Eesti OU]
ThermoFlo 12014-12-22
David Rothkopf [Pharma Systems Eesti OU]
Bact Trap HEPA2014-12-22
David Rothkopf [Pharma Systems Eesti OU]
Bact Trap HEPA Midi2014-12-22
David Rothkopf [Pharma Systems Eesti OU]
ThermoFlo Filter HCH2014-12-22
David Rothkopf [Pharma Systems Eesti OU]
Filter Flo2014-12-22
David Rothkopf [Pharma Systems Eesti OU]
Filter Flo2014-12-22
David Rothkopf [Pharma Systems Eesti OU]
Bact Trap2014-12-22
david Rothkopf [The Helping Hand Company]
Symmetrikit Chair2014-05-09
david Rothkopf [The Helping Hand Company]
Small Tiltrite2014-05-09
david Rothkopf [The Helping Hand Company]
Cricket2014-05-09
david Rothkopf [The Helping Hand Company]
Poser Swing2014-04-29
david Rothkopf [The Helping Hand Company]
Acheeva2014-04-06
david Rothkopf [The Helping Hand Company]
Symmetrisleep2013-12-31
David Rothkopf [3Shape A/S]
3Shape Communicate2013-07-02
David Rothkopf [3Shape A/S]
3Shape Articulator2012-03-04
David Rothkopf [Pharma Systems AB]
ThermoFlo Neo2011-06-06
David Rothkopf [Pharma Systems AB]
ThermoFlo Neo Port2011-06-06
David Rothkopf [Pharma Systems AB]
ThermoFlo Midi2011-06-06
David Rothkopf [Pharma Systems AB]
ThermoFlo Filter2011-06-06
David Rothkopf [Pharma Systems AB]
ThermoFlo Filter Port2011-06-06
David Rothkopf [Pharma Systems AB]
ThermoFlo Filter PhFlex2011-06-06
David Rothkopf [Pharma Systems AB]
ThermoFlo Filter Midi2011-06-06
David Rothkopf [Pharma Systems AB]
ThermoFlo Filter HCH2011-06-06
David Rothkopf [Pharma Systems AB]
ThermoFlo 1 Filter2011-06-06
David Rothkopf [Pharma Systems AB]
ThermoFlo 1 Filter Port2011-06-06
David Rothkopf [Pharma Systems AB]
ThermoFlo 1 Filter Port Elbow2011-06-06
David Rothkopf [Pharma Systems AB]
ThermoFlo 1 Filter Port Angle2011-06-06
David Rothkopf [Pharma Systems AB]
Pharma Trach Multi2011-06-06
David Rothkopf [Pharma Systems AB]
Pharma Trach Basic2011-06-06
David Rothkopf [Pharma Systems AB]
Pharma Suction2011-06-06
David Rothkopf [Pharma Systems AB]
Oxygen adapter2011-06-06
David Rothkopf [Pharma Systems AB]
ThermoFlo2011-06-06
David Rothkopf [Pharma Systems AB]
ThermoFlo 12011-06-06
David Rothkopf [Pharma Systems AB]
Filter Flo2011-06-06
David Rothkopf [Pharma Systems AB]
Bact Trap HEPA2011-06-06
David Rothkopf [Pharma Systems AB]
Bact Trap HEPA Midi2011-06-06
David Rothkopf [Pharma Systems AB]
ThermoFlo Filter HCH2011-06-06
David Rothkopf [Pharma Systems AB]
Filter Flo2011-06-06
David Rothkopf [Pharma Systems AB]
Bact Trap2011-06-06
David Rothkopf [3Shape A/S]
Trios Interoral Dental System2007-12-20
David Rothkopf [3Shape A/S]
Trios Interoral Dental System2007-12-20
David Rothkopf [3Shape A/S]
TRIOS Scanner2007-12-20
David Rothkopf [3Shape A/S]
TRIOS Scanner2007-12-20
David Rothkopf [3Shape A/S]
TRIOS Patient Monitoring2007-12-20
David Rothkopf [3Shape A/S]
TRIOS Patient Monitoring2007-12-20
David Rothkopf [3Shape A/S]
TRIOS 42007-12-20
David Rothkopf [3Shape A/S]
TRIOS 42007-12-20
David Rothkopf [3Shape A/S]
TRIOS 3 Wireles2007-12-20
David Rothkopf [3Shape A/S]
TRIOS 3 Wireles2007-12-20
David Rothkopf [3Shape A/S]
Novux E4 Scanner2007-12-20
David Rothkopf [3Shape A/S]
Novux E4 Scanner2007-12-20
David Rothkopf [3Shape A/S]
Novux E3 Scanner2007-12-20
David Rothkopf [3Shape A/S]
Novux E3 Scanner2007-12-20
David Rothkopf [3Shape A/S]
Novux E2 Scanner2007-12-20
David Rothkopf [3Shape A/S]
Novux E2 Scanner2007-12-20
David Rothkopf [3Shape A/S]
Novux E1 Scanner2007-12-20
David Rothkopf [3Shape A/S]
Novux E1 Scanner2007-12-20
David Rothkopf [3Shape A/S]
Novux D8502007-12-20
David Rothkopf [3Shape A/S]
Novux D8502007-12-20
David Rothkopf [3Shape A/S]
Novux D7502007-12-20
David Rothkopf [3Shape A/S]
Novux D7502007-12-20
David Rothkopf [3Shape A/S]
Novux D20002007-12-20
David Rothkopf [3Shape A/S]
Novux D20002007-12-20
David Rothkopf [3Shape A/S]
E4 Scanner2007-12-20
David Rothkopf [3Shape A/S]
E4 Scanner2007-12-20
David Rothkopf [3Shape A/S]
E3 Scanner2007-12-20
David Rothkopf [3Shape A/S]
E3 Scanner2007-12-20
David Rothkopf [3Shape A/S]
E2 Scanner2007-12-20
David Rothkopf [3Shape A/S]
E2 Scanner2007-12-20
David Rothkopf [3Shape A/S]
E1 scanner2007-12-20
David Rothkopf [3Shape A/S]
E1 scanner2007-12-20
David Rothkopf [3Shape A/S]
3Shape Dental System2007-12-20
David Rothkopf [3Shape A/S]
3Shape Dental System2007-12-20
David Rothkopf [3Shape A/S]
3Shape Anatomy Design2007-12-20
David Rothkopf [3Shape A/S]
3Shape Anatomy Design2007-12-20
David Rothkopf [3Shape A/S]
3D scanner R9002007-12-20
David Rothkopf [3Shape A/S]
3D scanner R9002007-12-20
David Rothkopf [3Shape A/S]
3D scanner R7102007-12-20
David Rothkopf [3Shape A/S]
3D scanner R7102007-12-20
David Rothkopf [3Shape A/S]
3D scanner R5002007-12-20
David Rothkopf [3Shape A/S]
3D scanner R5002007-12-20
David Rothkopf [3Shape A/S]
3D scanner D900L2007-12-20
David Rothkopf [3Shape A/S]
3D scanner D900L2007-12-20
David Rothkopf [3Shape A/S]
3D scanner D9002007-12-20
David Rothkopf [3Shape A/S]
3D scanner D9002007-12-20
David Rothkopf [3Shape A/S]
3D scanner D7102007-12-20
David Rothkopf [3Shape A/S]
3D scanner D7102007-12-20
David Rothkopf [3Shape A/S]
3D scanner D5002007-12-20
David Rothkopf [3Shape A/S]
3D scanner D5002007-12-20
David Rothkopf [3Shape A/S]
3D Scanner R8502007-12-20
David Rothkopf [3Shape A/S]
3D Scanner R8502007-12-20
David Rothkopf [3Shape A/S]
3D Scanner R7502007-12-20
David Rothkopf [3Shape A/S]
3D Scanner R7502007-12-20
David Rothkopf [3Shape A/S]
3D Scanner R7002007-12-20
David Rothkopf [3Shape A/S]
3D Scanner R7002007-12-20
David Rothkopf [3Shape A/S]
3D Scanner R20002007-12-20
David Rothkopf [3Shape A/S]
3D Scanner R20002007-12-20
David Rothkopf [3Shape A/S]
3D Scanner R10002007-12-20
David Rothkopf [3Shape A/S]
3D Scanner R10002007-12-20
David Rothkopf [3Shape A/S]
3D Scanner D8502007-12-20
David Rothkopf [3Shape A/S]
3D Scanner D8502007-12-20
David Rothkopf [3Shape A/S]
3D Scanner D8102007-12-20
David Rothkopf [3Shape A/S]
3D Scanner D8102007-12-20
David Rothkopf [3Shape A/S]
3D Scanner D8002007-12-20
David Rothkopf [3Shape A/S]
3D Scanner D8002007-12-20
David Rothkopf [3Shape A/S]
3D Scanner D7502007-12-20
David Rothkopf [3Shape A/S]
3D Scanner D7502007-12-20
David Rothkopf [3Shape A/S]
3D Scanner D7002007-12-20
David Rothkopf [3Shape A/S]
3D Scanner D7002007-12-20
David Rothkopf [3Shape A/S]
3D Scanner D20002007-12-20
David Rothkopf [3Shape A/S]
3D Scanner D20002007-12-20
David Rothkopf [3Shape A/S]
3D Scanner D10002007-12-20
David Rothkopf [3Shape A/S]
3D Scanner D10002007-12-20

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