Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021580182

FEI Number

3021580182

Entity Name

SPENTYS

City/State/Country

Forest Brussels-Capital Region, BE

Establishment Address

Bd de l'Humanite 292, 1190 Forest, Belgium, Forest Brussels-Capital Region 1190, BE

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Spentys (Owner Number: 10080545)

Owner / Operator Contact Address

Bd de l'Humanite 292, 1190 Forest, Belgium, Forest, BE-BRU 1190, BE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

B2 B8 A8 Q1 Q4 Q3 A2 A3 Q2 Q5 A1 A6 Q6 A4 H7 W2 W4 W1 H2 W3 H1 H4 H6 H5 H3

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2022-01-30
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2022-01-30
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2022-01-30

Official Correspondent

Florian De Boeck

US Agent Details

Jose Zefu Kimpalou Business: Kimpalou Consulting & Services LLC Email: us.agent.fda@kimpalou.com Phone: (703) 7059030

Related Public Records

Same Entity

Spentys

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 3021580182. Last updated year: 2026. Please use registration number 3021580182 when referencing this establishment in official correspondence.