Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003018304

FEI Number

3003018304

Entity Name

ECM EUROPE BV

City/State/Country

Gemert Noord-Brabant, NL

Establishment Address

Oost-Om 54, Gemert Noord-Brabant 5422VZ, NL

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

ECM Europe BV (Owner Number: 10084824)

Owner / Operator Contact Address

Oost-Om 54, Gemert, NL-NB 5422VZ, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Fluido Standard Set Fluido Trauma Set

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LGZ	Warmer, Thermal, Infusion Fluid	General Hospital	Class 2	880.5725	2025-11-17

Official Correspondent

No official correspondent registered.

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

ECM Europe BV

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 3003018304. Last updated year: 2026. Please use registration number 3003018304 when referencing this establishment in official correspondence.