Exini Diagnostics Ab

FDA Filings

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

FDA Registration(s)

• Registration Number: 3010146120
• FEI Number: 3010146120
• Name: EXINI DIAGNOSTICS AB
• Owner & Operator: EXINI Diagnostics AB
• Contact Address: Ideon Science Park Scheelevagen 27; LUND SE-M Skane lan [SE-12] SE-223 70 SE
• US Agent:
  • Karl Sjostrand
  • Progenics Pharmaceuticals Inc.
  • 646 9752500
  • 646 7073626
  • ksjostrand@progenics.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Ideon Science Park Scheelevagen 27; LUND Skane lan [SE-12], SE-223 70 SE
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 07350002333037 Exini Diagnostics AB	EXINI Bone 303	2023-04-14
GUDID 07350002337028 Exini Diagnostics AB	aPROMISE 702	2023-04-06
GUDID 07350002336021 Exini Diagnostics AB	PYLARIFY AI 602	2022-09-19
PMN K220590 EXINI Diagnostics AB	APROMISE X	2022-04-29
GUDID 07350002336014 Exini Diagnostics AB	PYLARIFY AI 601	2021-11-24
GUDID 07350002335017 Exini Diagnostics AB	aPROMISE 501	2021-08-12
PMN K211655 EXINI Diagnostics AB	APROMISE	2021-07-27
GUDID 07350002332030 Exini Diagnostics AB	aBSI 203	2019-12-23
GUDID 07350002331033 Exini Diagnostics AB	EXINI 103	2019-10-07
PMN K191262 | LLZ EXINI DIAGNOSTICS AB	aBSI	2019-10-04
PMN K191262 EXINI Diagnostics AB	ABSI	2019-08-05
PMN K122205 EXINI DIAGNOSTICS AB	EXINI	2012-08-15