Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010047139

FEI Number

3010047139

Entity Name

ADHERIUM (NZ) LTD

City/State/Country

Auckland, NZ

Establishment Address

Level 2, 63 Albert Street, Auckland 1010, NZ

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Adherium (NZ) Ltd (Owner Number: 10046590)

Owner / Operator Contact Address

Collins Square, Tower Four Level 18, 727 Collins Street, Melbourne AU, Victoria

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K182638

PMA Number

N/A

All Registered Proprietary Names

Hailie Sensor Hailie Sensor Hailie Sensor Hailie Sensor Hailie Sensor

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2019-06-11
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2018-03-27
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2018-09-24
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2017-09-24
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2019-06-19

Official Correspondent

Igbal Syre

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

Adherium (NZ) Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K163485	Adherium (Nz), Ltd.	SmartTouch	2017-08-30
K781467	Travenol Laboratories, S.A.	U-FLOAT VALVE 2D9023	1978-09-07

Similar Registrations

Registration Number	Establishment Name	Location
1110315	MYLAN PHARMACEUTICALS INC.	Morgantown, WV, US
3018783526	CEVA LOGISTICS NETHERLANDS BV (Venray)	Oostrum Limburgh, NL
3005998497	SUNMED AP, LTD.	ZHUHAI Guangdong, CN
3006852037	Omron Healthcare Manufacturing Vietnam Co., Ltd.	Ho Chi Minh City, VN
3006783791	GaleMed (Xiamen) Co., Ltd.	XIAMEN Fujian, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010047139. Last updated year: 2026. Please use registration number 3010047139 when referencing this establishment in official correspondence.