Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9614578

FEI Number

3009350167

Entity Name

NEA INTERNATIONAL BV

City/State/Country

MAASTRICHT-AIRPORT Limburg, NL

Establishment Address

Europalaan 31, MAASTRICHT-AIRPORT Limburg 6199AB, NL

Establishment Type(s)

Manufacture Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Nea International bv (Owner Number: 9035836)

Owner / Operator Contact Address

Europalaan 31, --, Maastricht-Airport, NL-LI 6199 AB, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PUSH BRACES PUSH BRACES PUSH BRACES PUSH BRACES PUSH BRACES

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2005-11-16
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	1998-12-10
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2005-11-16
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	1999-07-26
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2005-11-16

Official Correspondent

No official correspondent registered.

US Agent Details

Jerry Ditz Business: BraceLab Email: jditz@bracelab.com Phone: (888) 2358221

Related Public Records

Same Entity

Nea International bv

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-0006-2025	Ossur H F Grjothals 5 Reykjavik Iceland	1	Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101

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2242467	HAUSMANN ENTERPRISES, LLC	NORTHVALE, NJ, US
3008261717	XIAMEN COMPOWER MEDICAL TECH. CO., LTD.	Xiamen Fujian, CN
3010260768	VTS ONE MEMBER CO., Ltd.	Hai Phong City, VN
3011556461	COMFORT PLUS CORPORATION	New Taipei City, TW

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9614578. Last updated year: 2026. Please use registration number 9614578 when referencing this establishment in official correspondence.