Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3031562615

FEI Number

3031562615

Entity Name

INDES HEALTHCARE B.V.

City/State/Country

Enschede Overijssel, NL

Establishment Address

Josink Esweg 1, Enschede Overijssel 7545 PN, NL

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Indes Healthcare B.V. (Owner Number: 10090948)

Owner / Operator Contact Address

Josink Esweg 1, Enschede, NL-OV 7545 PN, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Fluido® Compact Holder for Warming Module

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2024-06-06

Official Correspondent

Mindy McCann

US Agent Details

Mindy McCann Email: USagent@qservegroup.com Phone: (424) 2718169

Related Public Records

Same Entity

Indes Healthcare B.V.

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 3031562615. Last updated year: 2026. Please use registration number 3031562615 when referencing this establishment in official correspondence.