Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3028012839

FEI Number

3028012839

Entity Name

HENROTEK A/S

City/State/Country

Roedding Syddanmark, DK

Establishment Address

Vestermarksvej 5, Roedding Syddanmark 6630, DK

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Henrotek A/S (Owner Number: 10091395)

Owner / Operator Contact Address

Vestermarksvej 5, Roedding, DK-83 6630, DK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NNW	Bag, Urine Collection, Leg, For External Use, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2024-09-19

Official Correspondent

Mette Christensen

US Agent Details

Marissa Vilchez Email: m.vilchez@mdssar.com Phone: (312) 9751694

Related Public Records

Same Entity

Henrotek A/S

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

View Entity Profile →

Similar Registrations

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3014615175	K-MED CO., LTD.	Yangzhou Jiangsu, CN
8022890	VALENTINE INTL. LTD.	HSICHIH CITY, TAIPEI HSIEN, TW
3013187142	ENDURE INDUSTRIES, INC.	Homer, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3028012839. Last updated year: 2026. Please use registration number 3028012839 when referencing this establishment in official correspondence.