Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8043905

FEI Number

3003208740

Entity Name

VITREX MEDICAL A/S

City/State/Country

HERLEV Hovedstaden, DK

Establishment Address

VASEKAER 6-8, HERLEV Hovedstaden DK-2730, DK

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

VITREX MEDICAL A/S (Owner Number: 9004387)

Owner / Operator Contact Address

VASEKAER 6-8, --, HERLEV, DK-NOTA DK-2730, DK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

VITREX WAX PLATE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GHY	Hematocrit, Tube, Rack, Sealer, Holder	Hematology	Class 2	864.6400	2016-08-31

Official Correspondent

PETER JORGENSEN

US Agent Details

Kevin Walls Business: Regulatory Insight, Inc. Email: kevin@reginsight.com Phone: (720) 9625412

Related Public Records

Same Entity

VITREX MEDICAL A/S

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 8043905. Last updated year: 2026. Please use registration number 8043905 when referencing this establishment in official correspondence.