Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004436821

FEI Number

3004436821

Entity Name

MALEM MEDICAL LTD

City/State/Country

NOTTINGHAM Nottinghamshire, GB

Establishment Address

10 WILLOW HOLT, LOWDHAM, NOTTINGHAM Nottinghamshire NG14 7EJ, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MALEM MEDICAL Ltd (Owner Number: 9061121)

Owner / Operator Contact Address

10 WILLOW HOLT, LOWDHAM, NOTTINGHAM, GB-NTT NG14 7EJ, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MALEM

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	2004-02-11

Official Correspondent

HILAL MALEM

US Agent Details

David Lennarz Business: Registrar corp Email: David.Lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

MALEM MEDICAL 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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004436821. Last updated year: 2026. Please use registration number 3004436821 when referencing this establishment in official correspondence.