Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007020251

FEI Number

3007020251

Entity Name

UNION MEDICO APS

City/State/Country

Copenhagen Hovedstaden, DK

Establishment Address

Fruebjergvej 3, Copenhagen Hovedstaden 2100, DK

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Union Medico Aps (Owner Number: 10087053)

Owner / Operator Contact Address

Fruebjergvej 3, Copenhagen, DK-84 2100, DK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K033696

PMA Number

N/A

All Registered Proprietary Names

90 NeedleGuide Assistant 45 NeedleGuide Assistant

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KZH	Introducer, Syringe Needle	General Hospital	Class 2	880.6920	2023-01-06

Official Correspondent

Michael Perthu

US Agent Details

Edward Wright Business: Martensen Wright PC Email: ew@usa-eurolaw.com Phone: (916) 4489088

Related Public Records

Same Entity

Union Medico Aps

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007020251. Last updated year: 2026. Please use registration number 3007020251 when referencing this establishment in official correspondence.