Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003883662

FEI Number

3003883662

Entity Name

AMBROISE

City/State/Country

ENSCHEDE Overijssel, NL

Establishment Address

Twekkeler Es 24, ENSCHEDE Overijssel NL7547 SM, NL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

AMBROISE (Owner Number: 9031391)

Owner / Operator Contact Address

Twekkeler Es 24, --, ENSCHEDE, NL-NOTA NL7547 SM, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Amber AFO GENUX 2 UTX

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	1997-08-21

Official Correspondent

N.G.A. van Leerdam

US Agent Details

C. Becker Business: BECKER ORTHOPEDIC Email: cbecker@beckerorthopedic.net Phone: (248) 5887480

Related Public Records

Same Entity

AMBROISE

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 3003883662. Last updated year: 2026. Please use registration number 3003883662 when referencing this establishment in official correspondence.