Adherium Nz L T D

FDA Filings

This page includes the latest FDA filings for Adherium Nz L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

NEW ZEALAND

AUSTRALIAN STOCK EXCHANGE

ADR

DUNS 590654401

FDA Registration(s)

• Registration Number: 3010047139
• FEI Number: 3010047139
• Name: ADHERIUM (NZ) LTD
• Owner & Operator: Adherium (NZ) Ltd
• Contact Address: Level 11, 16 Kingston Street ; Auckland NZ-AUK Auckland 1010 NZ
• Official Correspondent:
  • Chris Mander
  • 64-9-3072771-x
• US Agent:
  • Michael van der Woude
  • Emergo Global Representation LLC
  • 512 3279997
  • USAgent@ul.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Level 11, 16 Kingston Street ; Auckland Auckland, 1010 NZ
• Establishment Type:
  • Complaint File Establishment per 21 CFR 820.198
  • Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
GUDID 09421032180439 ADHERIUM (NZ) LIMITED	Hailie Sensor - for use only with ProAir HFA	2023-10-18
GUDID 09421032180415 ADHERIUM (NZ) LIMITED	Hailie Sensor - for use only with Symbicort MDI	2022-11-22
GUDID 09421032180408 ADHERIUM (NZ) LIMITED	Hailie Sensor - for use only with Symbicort MDI	2022-11-22
GUDID 09421032180385 ADHERIUM (NZ) LIMITED	Hailie Sensor - for use only with Ellipta DPI	2022-11-22
GUDID 00942103218039 ADHERIUM (NZ) LIMITED	Hailie Sensor - for use only with Ellipta DPI	2022-11-22
PMN K221994 Adherium (NZ) Ltd	Hailie Sensor NF0107 & NF0108	2022-10-04
PMN K220622 Adherium (NZ) Ltd	Hailie Sensor NF0106	2022-07-15
GUDID 09421032180422 ADHERIUM (NZ) LIMITED	Hailie Sensor - for use only with Symbicort MDI	2021-12-10
GUDID 09421032180330 ADHERIUM (NZ) LIMITED	Hailie Sensor - for use only with HandiHaler	2021-12-03
PMN K211233 Adherium (NZ) Ltd	Hailie Sensor NF0109	2021-08-18
GUDID 09421032180255 ADHERIUM (NZ) LIMITED	Hailie Sensor - for use only with QVAR HFA	2020-04-27
GUDID 09421032180231 ADHERIUM (NZ) LIMITED	hailie - For use only with Serevent HFA	2020-04-27
GUDID 09421032180200 ADHERIUM (NZ) LIMITED	Hailie Sensor - for use only with Flovent HFA	2020-04-27
GUDID 09421032180194 ADHERIUM (NZ) LIMITED	Hailie Sensor - for use only with Advair HFA	2020-04-27
GUDID 09421032180156 ADHERIUM (NZ) LIMITED	Hailie Sensor - for use only with QVAR HFA	2020-04-27
GUDID 94210321800596 ADHERIUM (NZ) LIMITED	Hailie Sensor - for use only with Bevespi Aerosphere	2019-06-20
PMN K182638 Adherium (NZ) Ltd	Hailie Sensor	2019-06-19
GUDID 94210321800589 ADHERIUM (NZ) LIMITED	Hailie Sensor - for use only with Symbicort MDI	2019-06-12
GUDID 94210321800572 ADHERIUM (NZ) LIMITED	Hailie Sensor - for use only with ProAir HFA	2019-06-12
GUDID 94210321800565 ADHERIUM (NZ) LIMITED	Hailie Sensor - for use only with QVAR HFA	2019-06-12
GUDID 94210321800503 ADHERIUM (NZ) LIMITED	Hailie Sensor - for use only with Flovent HFA	2019-06-12
GUDID 94210321800497 ADHERIUM (NZ) LIMITED	Hailie Sensor - for use only with Advair HFA	2019-06-12
GUDID 94210321800473 ADHERIUM (NZ) LIMITED	Hailie Sensor - for use only with Ventolin HFA	2019-06-12
GUDID 94210321800466 ADHERIUM (NZ) LIMITED	Hailie Sensor - for use only with ProAir HFA	2019-06-12
GUDID 94210321800459 ADHERIUM (NZ) LIMITED	Hailie Sensor - for use only with QVAR HFA	2019-06-12
GUDID 94210321800398 ADHERIUM (NZ) LIMITED	Hailie Sensor - for use only with Flovent HFA	2019-06-12
GUDID 94210321800381 ADHERIUM (NZ) LIMITED	Hailie Sensor - for use only with Advair HFA	2019-06-12
GUDID 94210321800367 ADHERIUM (NZ) LIMITED	Hailie Sensor - for use only with Ventolin HFA	2019-06-12
PMN K182573 Adherium (NZ) Ltd	Hailie Sensor	2019-06-07
PMN K181405 Adherium (NZ) Ltd	Hailie Sensor	2018-12-10
PMN K180407 Adherium (NZ) Ltd	Smartinhaler	2018-07-25
GUDID 94210321800534 ADHERIUM (NZ) LIMITED	hailie - For use only with Serevent HFA	2018-05-22
PMN K173310 Adherium (NZ) Ltd	SmartTouch	2018-03-26
PMN K163485 Adherium (NZ) Ltd	SmartTouch	2017-08-30