Passarini Regulatory Affairs

FDA Filings

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

FDA Registration(s)
Registration Number3015330458
FEI Number3015330458
NamePassarini Regulatory Affairs of America
Owner & OperatorVolmed Brasil Equipamentos Ltda
Contact AddressAv. Sao Gabriel 291
Sao Carlos BR-SP Sao Paulo 13574540 BR
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address201 S. Biscayne Blvd, Suite 1200
Miami, FL 33131 US
Establishment TypeRepack or Relabel Medical Device

Registration Number3015775866
FEI Number3015775866
NamePassarini Regulatory Affairs of America
Owner & OperatorIMPLACIL DE BORTOLI MATERIAL ODONTOLOGICO LTDA
Contact AddressRUA VICENTE DE CARVALHO, 178-182
Sao Paulo BR-SP Sao Paulo 01521020 BR
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address201 S. Biscayne Blvd, Suite 1200
Miami, FL 33131 US
Establishment Type
  • Manufacture Medical Device
  • Repack or Relabel Medical Device

FDA Filings

Device
Company
DeviceDate
Passarini Regulatory Affairs of America [IMPLACIL DE BORTOLI MATERIAL ODONTOLOGICO LTDA]
Implacil Implant System2020-02-13
Passarini Regulatory Affairs of America [IMPLACIL DE BORTOLI MATERIAL ODONTOLOGICO LTDA]
Implacil Implant System2020-02-13
Passarini Regulatory Affairs of America [IMPLACIL DE BORTOLI MATERIAL ODONTOLOGICO LTDA]
Accessories, Implant, Dental, Endosseous2019-08-09
Passarini Regulatory Affairs of America [IMPLACIL DE BORTOLI MATERIAL ODONTOLOGICO LTDA]
Tray, Surgical, Instrument2019-08-09
Passarini Regulatory Affairs of America [Volmed Brasil Equipamentos Ltda]
Blade, Saw, General & Plastic Surgery, Surgical2019-05-10
Passarini Regulatory Affairs of America [Volmed Brasil Equipamentos Ltda]
Accessories, Arthroscopic2019-04-15

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