Hygitech

FDA Filings

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

FDA Registration(s)
Registration Number3015536911
FEI Number3015536911
NameHYGITECH INC USA
Owner & OperatorHYGITECH
Contact Address109 bis avenue Charles de Gaulle
Neuilly-sur-Seine FR-J Ile-de-France 92200 FR
Official Correspondent
  • Michael Stemmer
  • 33-01-48013289-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address60 BROAD STREET SUITE 3502
New York, NY 10004 US

Registration Number3015167975
FEI Number3015167975
NameDavid Lennarz
Owner & OperatorHYGITECH
Contact Address109 bis avenue Charles de Gaulle
Neuilly-sur-Seine FR-J Ile-de-France 92200 FR
Official Correspondent
  • Michael Stemmer
  • 33-01-48013289-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address144 Research Drive
Hampton, VA 23666 US
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device
Company
DeviceDate
HYGITECH
 HYGITECH HY-900212020-12-24
HYGITECH
 HYGITECH HY-980112020-12-24
HYGITECH
 HYGITECH HY-980122020-12-24
HYGITECH
 HYGITECH HY-980132020-12-24
HYGITECH
 HYGITECH HY-980142020-12-24
HYGITECH
 HYGITECH HY-980152020-12-24
HYGITECH
 HYGITECH HY-980162020-12-24
HYGITECH
 HYGITECH HY-980172020-12-24
HYGITECH
 HYGITECH HY-980212020-12-24
HYGITECH
 HYGITECH HY-980222020-12-24
HYGITECH
 HYGITECH HY-980232020-12-24
HYGITECH
 HYGITECH HY-980342020-12-24
HYGITECH
 HYGITECH HY-980312020-12-24
HYGITECH
 HYGITECH HY-980322020-12-24
HYGITECH
 HYGITECH HY-980332020-12-24
HYGITECH
 HYGITECH HY-980412020-12-24
HYGITECH
 HYGITECH 2020-12-24
HYGITECH
 HYGITECH HY-980432020-12-24
HYGITECH
 HYGITECH HY-981012020-12-24
HYGITECH
 HYGITECH HY-981022020-12-24
HYGITECH
 HYGITECH HY-981032020-12-24
HYGITECH
 HYGITECH HY-981042020-12-24
HYGITECH
 HYGITECH HY-981052020-12-24
HYGITECH
 HYGITECH HY-981112020-12-24
HYGITECH
 HYGITECH HY-981122020-12-24
HYGITECH
 HYGITECH HY-981132020-12-24
HYGITECH
 HYGITECH HY-981142020-12-24
HYGITECH
 HYGITECH HY-981152020-12-24
HYGITECH
 HYGITECH HY-981162020-12-24
HYGITECH
 HYGITECH HY-981212020-12-24
HYGITECH
 HYGITECH HY-981222020-12-24
HYGITECH
 HYGITECH HY-981232020-12-24
HYGITECH
 HYGITECH HY-981242020-12-24
HYGITECH
 HYGITECH HY-981252020-12-24
HYGITECH
 HYGITECH HY-981262020-12-24
HYGITECH
 HYGITECH HY-982012020-12-24
HYGITECH
 HYGITECH HY-982022020-12-24
HYGITECH
 HYGITECH HY-982032020-12-24
HYGITECH
 HYGITECH HY-982042020-12-24
HYGITECH
 HYGITECH HY-982052020-12-24
HYGITECH
 HYGITECH HY-982112020-12-24
HYGITECH
 HYGITECH HY-982122020-12-24
HYGITECH
 HYGITECH HY-982132020-12-24
HYGITECH
 HYGITECH HY-982142020-12-24
HYGITECH
 HYGITECH HY-982212020-12-24
HYGITECH
 HYGITECH HY-982222020-12-24
HYGITECH
 HYGITECH HY-982232020-12-24
HYGITECH
 HYGITECH HY-982242020-12-24
HYGITECH
 HYGITECH HY-038112020-12-24
HYGITECH
 HYGITECH HY-090112020-12-24
HYGITECH
 HYGITECH HY-088112020-12-24
HYGITECH
 HYGITECH HY-085112020-12-24
HYGITECH
 HYGITECH HY-04212020-12-24
HYGITECH
 HYGITECH HY-09912020-12-24
HYGITECH
 HYGITECH HY-09812020-12-24
HYGITECH
 HYGITECH HY-09212020-12-24
HYGITECH
 HYGITECH HY-50112020-12-24
HYGITECH
 HYGITECH HY-1300142020-12-24
HYGITECH
 HYGITECH HY-1100092020-12-24
HYGITECH
 HYGITECH HY-1100222020-12-24
HYGITECH
 HYGITECH HY-120392020-12-24
HYGITECH
 HYGITECH HY-120362020-12-24
HYGITECH
 HYGITECH HY-120332020-12-24
HYGITECH
 HYGITECH HY-1100112020-12-23
HYGITECH
 HYGITECH HY-1100072020-12-23
HYGITECH
 HYGITECH HY-1100032020-12-23
HYGITECH
 HYGITECH HY-059022020-12-23
HYGITECH
 HYGITECH HY-500162020-12-23
HYGITECH
 HYGITECH HY-500182020-12-23
HYGITECH
 HYGITECH HY-500192020-12-23
HYGITECH
 HYGITECH HY-500172020-12-23
HYGITECH
 HYGITECH HY-500152020-12-23
HYGITECH
 HYGITECH HY-500132020-12-23
HYGITECH
 HYGITECH HY-500212020-12-23
HYGITECH
 HYGITECH HY-0662020-12-23
HYGITECH
 HYGITECH HY-0642020-12-23
HYGITECH
 HYGITECH HY-0622020-12-23
HYGITECH
 HYGITECH HY-0602020-12-23
HYGITECH
 HYGITECH HY-057022020-12-23
HYGITECH
 HYGITECH HY-1300252020-12-23
HYGITECH
 HYGITECH HY-5212020-12-23
HYGITECH
 HYGITECH HY-5182020-12-23
HYGITECH
 HYGITECH HY-5192020-12-23
HYGITECH
 HYGITECH HY-500332020-12-23
HYGITECH
 HYGITECH HY-500272020-12-23
HYGITECH
 HYGITECH HY-5202020-12-23
HYGITECH
 HYGITECH HY-120142020-12-23
HYGITECH
 HYGITECH HY-120402020-12-23
HYGITECH
 HYGITECH HY-1100052020-12-23
HYGITECH
 HYGITECH HY-1100182020-12-23
HYGITECH
 HYGITECH HY-1100422020-12-23
HYGITECH
 HYGITECH HY-3012020-12-23
HYGITECH
 HYGITECH HY-070112020-12-23
HYGITECH
 HYGITECH HY-070152020-12-23
HYGITECH
 HYGITECH HY-0582020-12-23
HYGITECH
 HYGITECH HY-0552020-12-23
HYGITECH
 HYGITECH HY-0572020-12-23
HYGITECH
 HYGITECH HY-900162020-12-23
HYGITECH
 HYGITECH HY-900102020-12-23
HYGITECH
 HYGITECH HY-900202020-12-22
David Lennarz [HYGITECH]
BONE MILL, BONE CRACKER2019-07-10
David Lennarz [HYGITECH]
RETRACTOR2019-07-10
David Lennarz [HYGITECH]
SCALPEL HOLDERS, SCALPEL BLADE, SCALPEL HANDLES ROUND STRAIGHT2019-07-10
David Lennarz [HYGITECH]
BONE MATERIAL MIXING BOWL, SPOON AND COMPACTOR ERGONOMIC2019-07-10
David Lennarz [HYGITECH]
CALIPER, PROBE, FLEXIEXPLORER, PARALLELING GUIDE JAPAN MODELL2019-07-10
David Lennarz [HYGITECH]
MASK SURGICAL2019-04-29
David Lennarz [HYGITECH]
surgical gown2019-04-29
David Lennarz [HYGITECH]
surgical gown2019-04-29
David Lennarz [HYGITECH]
General Surgery Tray - SURGICAL PROCEDURE PACKS2019-04-15
David Lennarz [HYGITECH]
SURGICAL PROCEDURE PACKS - SURGICAL GOWN2019-04-15
David Lennarz [HYGITECH]
ISOLATION GOWN, STERILE OR NON STERILE2019-01-25
David Lennarz [HYGITECH]
FACE SHIELD2019-01-23
David Lennarz [HYGITECH]
LED PORTABLE HEADLIGHT2019-01-23
David Lennarz [HYGITECH]
SURGICAL CAP WITH LACES, NON-WOVEN BOUFFANT CAP, WHITE BOUFFANT CLIP CAP, ASTRONAUT CAP2019-01-23
David Lennarz [HYGITECH]
STERILE ADHESIVE PROTECTION FILM2019-01-23
David Lennarz [HYGITECH]
INFUSION STAND2019-01-23
David Lennarz [HYGITECH]
NON-STERILE ADHESIVE PROTECTION TAPE, STERILE ADHESIVE PROTECTION FILM, X-RAY GENERATOR COVERS2019-01-23
David Lennarz [HYGITECH]
STERILE IRRIGATION SET2019-01-23
David Lennarz [HYGITECH]
TORQUE WRENCH WITH INTERCHANGEABLE TIPS, BONE SCRAPER AND REPLACEMENT BLADE, TUNNELING INSTRUMENT, FLEXIBLE GAUGE,2019-01-18
David Lennarz [HYGITECH]
Miror Sterile, 3 instruments pack, 11 instruments Pack2019-01-18
David Lennarz [HYGITECH]
MOUTH GAGS MOLT, MOUTH PROP MCKESSON2019-01-18
David Lennarz [HYGITECH]
WIRE TWISTING INSTRUMENTS MERVILLE2019-01-18
David Lennarz [HYGITECH]
TWEEZERS TITANIUM COLLEGE, TISSUE PLIERS ANATOMICAL ADSON, TITANIUM PLIERS FOR SCREWS, TITANIUM FORCEPS FOR IMPLANTOLOGY2019-01-18
David Lennarz [HYGITECH]
HAMMER MEAD, HAMMER FOR BONE CRACKER WITH ALUMINUM HANDLE2019-01-18
David Lennarz [HYGITECH]
BLADE OF SCALPEL2019-01-18
David Lennarz [HYGITECH]
NON-WOVEN OVERSHOES, NON-SLIP OVERSHOES, WATERPROOF OVERSHOES ,SURGICAL NON STERILE SUITS2019-01-18
David Lennarz [HYGITECH]
SAMPLE BAG, CASSETTE2019-01-18
David Lennarz [HYGITECH]
CURETTE, MINI SCALER2019-01-18
David Lennarz [HYGITECH]
MINI-STRIPPERS, RETRACTOR , PERIOSTEAL ELEVATOR OBWEGESER, NERVE REPOSITION INSTRUMENT, NASAL RASPS WIENER2019-01-18
David Lennarz [HYGITECH]
PROBE WITH TITANIUM TIP AND ZIRCON NITRID COATING,2019-01-18
David Lennarz [HYGITECH]
GINGIVECTOMY KNIFE KIRKLAND2019-01-18
David Lennarz [HYGITECH]
CHISELS ROUND, MINI SCALER2019-01-18
David Lennarz [HYGITECH]
SINUS LIFT INSTRUMENT BUSER, ELEVATOR,SINUS-LIFT INSTRUMENT, MAXILLARY MOBILIZER, OSTEOTOME ELASTIC BLADE, OSTEOTOME2019-01-18
David Lennarz [HYGITECH]
LUXATOR, SYNDESMOTOME SICKLE , BERNARD ROOT ELEVATORS, ROOT ELEVATORS SELDIN2019-01-18
David Lennarz [HYGITECH]
BONE RONGEURS FRIEDMAN, BONE RONGEURS RUSKLIN-LISTON, BONE RONGEURS STILLE-LISTON, BONE HOLDING FORCEPS BONE BLOCk,LLIAC RETRACTORS2019-01-18
David Lennarz [HYGITECH]
ELEVATOR H WITH TITANIUM HANDLE, EXTRACTING FORCEPS, EXTRACTING FORCEPS AMERIACAN2019-01-18
David Lennarz [HYGITECH]
CIRCULAR KNIFE2019-01-18
David Lennarz [HYGITECH]
BONE HOLDING FORCEP ROCHESTER-PEAN2019-01-18
David Lennarz [HYGITECH]
CURETTE , IMPLANT SCALER,2019-01-18
David Lennarz [HYGITECH]
BONE CURETTE HEMINGWAY, BONE CURETTE LUCAS2019-01-18
David Lennarz [HYGITECH]
MIRROR HANDLE, MOUTH MIRROR IN INOX2019-01-18
David Lennarz [HYGITECH]
COMPACTOR CLARIZIO, WIRE PUSHER DAUTREY, GAUZE PACKERS LUNIATSCHEK, SINUS RETRACTOR2019-01-18
David Lennarz [HYGITECH]
RETRACTORS , MANDIBULAR AWL, ZYGOMATIC ARCH AWL ,NASAL FORCEPS,ZYGOMATIC INSTRUMENT, GAUZE PACKERS RHINOLOGY FORCEPS2019-01-18
David Lennarz [HYGITECH]
RETRACTOR DAUTREY RETRACTOR STERNBERG ,CHEEK RETRACTOR MINNESOTA ICRM ,RETRACTOR LASTER2019-01-18
David Lennarz [HYGITECH]
Protective anti-UV glasses2019-01-17
David Lennarz [HYGITECH]
MAGNIFYING LENS x2.5, MAGNIFYING LENS x3.52019-01-17
David Lennarz [HYGITECH]
BOTTLE, COLLECTION, VACUUM, 1300ML, 1800ML, 3200ML2019-01-07
David Lennarz [HYGITECH]
SYRINGES2019-01-07
David Lennarz [HYGITECH]
TRAY, IMPRESSION2019-01-07
David Lennarz [HYGITECH]
SCISSORS, CASTROVIEJO2019-01-07
David Lennarz [HYGITECH]
BONE HOLDING FORCEPS2019-01-07
David Lennarz [HYGITECH]
BAND INSTRUMENTS2019-01-07
David Lennarz [HYGITECH]
ASPIRATORS2019-01-07
David Lennarz [HYGITECH]
ADAPTERS FOR SUCTION CANNULA, SURGICAL ASPIRATION SET WITH BONE FILTER, SURGICAL CANNULA, ADAPTERS FOR SUCTION CANNULA,2019-01-07
David Lennarz [HYGITECH]
MOUTH MIRRORS AND HANDLES2019-01-07
David Lennarz [HYGITECH]
NEEDLE HOLDER2019-01-07

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2019103140052Anvers,Belgium -> New York/Newark Area, Newark, New JerseySURGICAL INSTRUMENTS HS CODE 901849903 PKG
2019102261275Anvers,Belgium -> New York/Newark Area, Newark, New JerseySURGICAL INSTRUMENTS HS CODE 901849903 PKG
2019082973868Le Havre,France -> New York/Newark Area, Newark, New JerseyINSTANT FREEZ AND COUSSIN THERMIQUE337 CTN
2019082058817Le Havre,France -> New York/Newark Area, Newark, New JerseyINSTANT FREEZE AND COUSSIN TERHMIQUE337 CTN
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