Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018240701

FEI Number

3018240701

Entity Name

NOTE Herrljunga AB

City/State/Country

Herrljunga Vastra Gotaland, SE

Establishment Address

Ostergardsgatan 19, Herrljunga Vastra Gotaland 52433, SE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

NOTE Herrljunga AB (Owner Number: 10085363)

Owner / Operator Contact Address

Ostergardsgatan 19, Herrljunga, SE-O 52433, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

TENA

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	2022-06-08

Official Correspondent

Jasmin Hasak

US Agent Details

Rebecca Russo Business: Essity HMS North America Inc. Email: rebecca.russo@essity.com Phone: (845) 7453574

Related Public Records

Same Entity

NOTE Herrljunga AB

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 3018240701. Last updated year: 2026. Please use registration number 3018240701 when referencing this establishment in official correspondence.