Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003898328

FEI Number

3003898328

Entity Name

BASKO HEALTHCARE B.V.

City/State/Country

ZAANDAM Noord-Holland, NL

Establishment Address

PIETER LIEFTINCKWEG 16, ZAANDAM Noord-Holland 1505 HX, NL

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Export Device to the United States But Perform No Other Operation on Device,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

BANDAGE-EN CORSETINDUSTRIE BASKO B.V. (Owner Number: 9053038)

Owner / Operator Contact Address

Pieter Lieftinckweg 16, Zaandam, NL-NH 1505HX, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

P.E.A.care splint MultiStatic joints MultiStatic Free Motion joints MultiMotion Corrective System Joint MultiMotion Free Movement Joint CMCcare MultiMotion System Bars IQ Components Swing Phase Lock Binky joints IQ COMPONENTS SWIN Stomacare BASKO DISCOFLEX

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITN	Splint, Denis Brown	Physical Medicine	Class 1	890.3675	2013-04-16
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2013-04-15
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2016-09-28
ITC	Stirrup, External Brace Component	Physical Medicine	Class 1	890.3410	2013-04-15
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2002-09-19
EXN	Support, Hernia	Gastroenterology, Urology	Class 1	876.5970	2018-01-16
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2006-04-25

Official Correspondent

Amy Eikelenboom

US Agent Details

A. Cole Business: Fillauer LLC Email: acole@fillauer.com Phone: (423) 6240946

Related Public Records

Same Entity

BANDAGE-EN CORSETINDUSTRIE BASKO 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 3003898328. Last updated year: 2026. Please use registration number 3003898328 when referencing this establishment in official correspondence.