Bios S R L

FDA Filings

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

FDA Registration(s)

• Registration Number: 3004940677
• FEI Number: 3008108972
• Name: BIOS S.R.L.
• Owner & Operator: BIOS S.R.L.
• Contact Address: VIA GUIDO ROSSA, 10/12 --; VIMODRONE (MILAN) IT-NOTA I-20090 IT
• US Agent:
  • Alessandro Franchi
  • 714 6988430 0
  • franchi.alessandro@gmail.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: VIA GUIDO ROSSA, 10/12 ; VIMODRONE Milano, I-20090 IT
• Establishment Type: Manufacture Medical Device

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
GUDID 08052049500289 BIOS SRL	OptiPLUS	2023-11-14
GUDID 08052049500272 BIOS SRL	OptiPLUS	2023-08-31
GUDID 08052049500227 BIOS SRL	OptiStream	2022-10-12
GUDID 08052049500210 BIOS SRL	NUERA TIGHT 1ch Paris Edition	2022-07-14
GUDID 08052049500197 BIOS SRL	FEMINESS	2021-11-10
GUDID 08052049500135 BIOS SRL	FEMINESS tip	2021-11-10
GUDID 08052049500012 BIOS SRL	SUPERBIUM	2021-08-24
PMN K210867 BIOS S.r.l.	NuEra Tight RF, NuEra Tight RF Plus	2021-04-21
PMN K201239 Bios S.r.l.	NuEra Tight Family, EMS Model	2020-12-31
GUDID 08052049500050 BIOS SRL	NUERA	2020-11-30
GUDID 08052049500043 BIOS SRL	BIOREVITAL RF MED	2020-11-30
GUDID 08052049500005 BIOS SRL	THERMI 250	2020-11-30
GUDID 08052049500111 BIOS SRL	NUERA TIGHT	2020-07-07
GUDID 08052049500067 BIOS SRL	SPLENDOR X ALEX + Nd:YAG	2020-02-06
GUDID 08052049500029 BIOS SRL	SQUARE EPIL ALEX + Nd:YAG	2020-02-06
GUDID 08052049500104 BIOS SRL	NUERA TIGHT	2019-05-14
PMN K161632 | GEX BIOS S.R.L.	SQUARE EPIL Nd:YAG	2017-02-10
PMN K161632 | GEX BIOS S.R.L.	SQUARE EPIL ALEX	2017-02-10
PMN K161632 | GEX BIOS S.R.L.	SQUARE EPIL ALEX2	2017-02-10
PMN K161632 | GEX BIOS S.R.L.	SQUARE EPIL ALEX + Nd:YAG	2017-02-10
PMN K161632 | GEX BIOS S.R.L.	SPLENDOR X Nd:YAG	2017-02-10
PMN K161632 | GEX BIOS S.R.L.	SPLENDOR X ALEX	2017-02-10
PMN K161632 | GEX BIOS S.R.L.	SPLENDOR X ALEX2	2017-02-10
PMN K161632 | GEX BIOS S.R.L.	SPLENDOR X ALEX + Nd:YAG	2017-02-10
PMN K161632 BIOS S.R.L.	FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)	2016-12-08
PMN K153229 | ONG BIOS S.R.L.	Superbium	2016-05-03
PMN K153229 | ONF BIOS S.R.L.	Superbium	2016-05-03
PMN K153229 | GEX BIOS S.R.L.	Superbium	2016-05-03
PMN K153229 BIOS S.R.L	Superbium	2016-04-12
PMN K151296 | PBX BIOS S.R.L.	NuERA	2016-02-18
PMN K151296 | PBX BIOS S.R.L.	NUERA Tight	2016-02-18
PMN K151296 | PBX BIOS S.R.L.	Biorevital RF MED	2016-02-18
PMN K151296 BIOS S.R.L.	Family Of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250)	2015-11-19
PMN K080374 BIOS S.R.L.	BIOSYAG MEDICAL SYSTEM	2008-05-15
PMN K072344 BIOS S.R.L.	APL MEDICAL SYSTEM	2007-12-03
PMN K043521 BIOS S.R.L.	BIOSYAG 50 MED	2005-03-24

Similar & Related FDA Registered Companies

• BioSAF IN Srl
• BIOSIGMA SRL
• Biosensors International Pte Ltd
• BIOSENSORS INTERNATIONAL-USA
• Biosense Webster, Inc.31 Technology Drive, Suite 200irvine, CA 92618 PMA NumberP210027 Date Received07/06/2021 Decision Date11/23/2022 Product Codes OAD OAE  Advisory Committee Cardiovascular Clinical TrialsNCT03775512 Expedited Review Granted? No
• Biosense Webster, Inc31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP950005 Supplement NumberS085 Date Received09/02/2022 Decision Date09/30/2022 Product Code LPB  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP010068 Supplement NumberS070 Date Received09/02/2022 Decision Date09/30/2022 Product Code OAD  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP030031 Supplement NumberS128 Date Received09/02/2022 Decision Date09/30/2022 Product Code OAD  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP990071 Supplement NumberS056 Date Received09/02/2022 Decision Date09/30/2022 Product Code LPB  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP040036 Supplement NumberS090 Date Received09/02/2022 Decision Date09/30/2022 Product Code LPB  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP990025 Supplement NumberS070 Date Received09/02/2022 Decision Date09/30/2022 Product Code DRF  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Biosense Webster, Inc31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP950005 Supplement NumberS084 Date Received06/10/2022 Decision Date09/09/2022 Product Code LPB  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• BIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP990025 Supplement NumberS069 Date Received06/10/2022 Decision Date09/09/2022 Product Code DRF  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• BIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP040036 Supplement NumberS089 Date Received06/10/2022 Decision Date09/09/2022 Product Code LPB  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• BIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP030031 Supplement NumberS127 Date Received06/10/2022 Decision Date09/09/2022 Product Code OAD  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• BIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP010068 Supplement NumberS069 Date Received06/10/2022 Decision Date09/09/2022 Product Code OAD  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• BIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP990071 Supplement NumberS054 Date Received05/18/2022 Decision Date06/08/2022 Product Code LPB  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Biosensors International USA, Inc.1013 Centre Rd.suite 228wilmington, DE 19805 PMA NumberP190020 Date Received08/16/2019 Decision Date04/14/2022 Product Code NIQ  Advisory Committee Cardiovascular Clinical TrialsNCT02843633 Expedited Review Granted? No
• BIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP990071 Supplement NumberS053 Date Received02/16/2022 Decision Date03/15/2022 Product Code LPB  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BioSafe Distributors, LLC
• Biosilk Health and Beauty Sanitizer Spray Lavender
• BIOSENSE WEBSTER (ISRAEL) LTD.

Related Finance Registrations

NCAGE Code	AF166	BIOS SRL
CAGE Code	AF166	BIOS SRL

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2018011213075	South Riding Point,Bahamas -> Houston, Texas	MEDICAL DEVICES	20 PKG