Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9613434

FEI Number

3011251006

Entity Name

ANZACARE LTD.

City/State/Country

Waikanae Wellington, NZ

Establishment Address

13 Mahara Place, Waikanae Wellington 5036, NZ

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ANZACARE LTD. (Owner Number: 9014292)

Owner / Operator Contact Address

13 Mahara Place, --, Waikanae, NZ-WGN 5036, NZ

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

DRI Excel DRI Eclipse

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KPN	Alarm, Conditioned Response Enuresis	Gastroenterology, Urology	Class 2	876.2040	1997-01-30

Official Correspondent

No official correspondent registered.

US Agent Details

Raymond Halsey-Franke Business: Urocare Products Inc Email: ops@urocare.com Phone: (909) 6216013

Related Public Records

Same Entity

ANZACARE 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
K780660	Nite Train-R Enterprises, Inc.	NITE TRAIN'R	1978-07-28
K871787	Dilorenzo Engineering Co.	ENURESIS ALARM	1987-08-10

Similar Registrations

Registration Number	Establishment Name	Location
3005555608	RODGER B.V.	Ravenstein Noord-Brabant, NL
3010540632	Marvelworks Ltd.	Chai Wan, HK
3012375800	FOSHAN RM PRODUCTS CO., LTD	Foshan Guangdong, CN
3035544212	WICKED SHEETS D/B/A WICKED TECHNOLOGIES	Louisville, KY, US
3010177964	DR SAGI YAACOV LTD	haifa Northern, IL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9613434. Last updated year: 2026. Please use registration number 9613434 when referencing this establishment in official correspondence.