Asa S R L

FDA Filings

This page includes the latest FDA filings for Asa 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: 3004724437
• FEI Number: 3004724437
• Name: Michael van der Woude
• Owner & Operator: ASA S.R.L.
• Contact Address: VIA GALILEO GALILEI, 23 --; ARCUGNANO (VI) IT-NOTA 36057 IT
• Official Correspondent:
  • LUCIO - ZAGHETTO
  • 39-0444-289200-x
• US Agent:
  • Michael van der Woude
  • Emergo Global Representation LLC
  • 512 3279997
  • 512 3279998
  • USAgent@ul.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2500 Bee Cave Road, Bldg 1, Suite 300; Austin, TX 78746 US
• Establishment Type: Manufacture Medical Device

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
GUDID 08033765391689 ASA SRL	M7	2023-11-29
ILY Michael van der Woude [ASA S.R.L.]	M8	2019-01-30
PMN K111901 | ILY Michael van der Woude [ASA S.R.L.]	MPHI	2012-01-09
PMN K051922 | ILY Michael van der Woude [ASA S.R.L.]	MLS MIX5	2005-11-07
PMN K051922 | ILY Michael van der Woude [ASA S.R.L.]	MLS M6	2005-11-07
PMN K051922 | ILY Michael van der Woude [ASA S.R.L.]	MLS M1	2005-11-07

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• Asahi Kasei Medical Co., Ltd.1-105 Kanda Jinbochochiyoda-kutokyo 101-8-8101 PMA NumberP820033 Supplement NumberS016 Date Received12/09/2022 Decision Date01/05/2023 Product Code MDP  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No

Related Finance Registrations

NCAGE Code	A0265	ASA SRL
CAGE Code	A0265	ASA SRL