Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006715577

FEI Number

3006715577

Entity Name

A/S KURT HANSEN

City/State/Country

Svendborg Syddanmark, DK

Establishment Address

Gotlandsvej 5, Svendborg Syddanmark 5700, DK

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

A/S Kurt Hansen (Owner Number: 10058367)

Owner / Operator Contact Address

Gotlandsvej 5, Svendborg, DK-83 5700, DK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Mequ M Station

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BSB	Warmer, Blood, Non-Electromagnetic Radiation	Hematology	Class 2	864.9205	2026-06-18
LGZ	Warmer, Thermal, Infusion Fluid	General Hospital	Class 2	880.5725	2026-06-18

Official Correspondent

Soren Jensen

US Agent Details

Stephan Toupin Business: Dawa Medical LLC (USA) Email: stoupin@dawamedical.com Phone: (305) 5999373

Related Public Records

Same Entity

A/S Kurt Hansen

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
K090508	Belmont Instrument Corp.	THE BELMONT BUDDY LITE FLUID WARMER	2009-03-26

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9616567	ICU Medical Healthcare Manufacturing S.A. de C.V.	APODACA Nuevo Leon, MX
3012307300	ICU Medical, Inc.	Minneapolis, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006715577. Last updated year: 2026. Please use registration number 3006715577 when referencing this establishment in official correspondence.