Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006800085

FEI Number

3006800085

Entity Name

IHB OPERATIONS

City/State/Country

Zwolle Overijssel, NL

Establishment Address

Ceintuurbaan 15 B2, Zwolle Overijssel 8022 AW, NL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

IHB operations (Owner Number: 10027684)

Owner / Operator Contact Address

Ceintuurbaan 15 B2, Zwolle, NL-OV 8022 AW, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Ergon series Skybooms Freedom series Skybooms Various models of Skybooms

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FQO	Table, Operating-Room, Ac-Powered	General, Plastic Surgery	Class 1	878.4960	2008-11-24

Official Correspondent

Roderik Erens

US Agent Details

Alan P Schwartz Business: MDI Consultants, Inc. Email: Alan@mdiconsultants.com Phone: (516) 4829001

Related Public Records

Same Entity

IHB operations

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0036-2024	Getinge Usa Sales Inc	1	Meera Mobile Operating Table-to support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Model Number: 7200.01F2

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3006105501	DRASHTI MEDICAL SOLUTIONS, LLC	Rockledge, FL, US
3027847726	Paras Surgico Factory	Delhi, IN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006800085. Last updated year: 2026. Please use registration number 3006800085 when referencing this establishment in official correspondence.