Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009694288

FEI Number

3009694288

Entity Name

Comecer Netherlands b.v.

City/State/Country

Joure Fryslan, NL

Establishment Address

Madam Curieweg 1, Joure Fryslan nl/8501AC, NL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Comecer Netherlands (Owner Number: 10041109)

Owner / Operator Contact Address

Madam Curieweg 1, Joure, NL-FR 8501XC, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K142325

PMA Number

N/A

All Registered Proprietary Names

IBC-dose calibrator XR IBC-dose calibrator VDC-606 VDC-606XR

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KPT	Calibrator, Dose, Radionuclide	Radiology	Class 2	892.1360	2014-09-22

Official Correspondent

Frits Pen

US Agent Details

Mindy McCann Business: Qserve Group US, Inc. Email: USagent@qservegroup.com Phone: (424) 2718169

Related Public Records

Same Entity

Comecer Netherlands

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 3009694288. Last updated year: 2026. Please use registration number 3009694288 when referencing this establishment in official correspondence.