3D-SHAPER MEDICAL S.L.

FDA Device Registration & Listing · Barcelona, ES · Registration 3026043045

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3026043045
FEI Number
3026043045
Entity Name
3D-SHAPER MEDICAL S.L.
City/State/Country
Barcelona, ES
Establishment Address
Rambla Catalunya, 53, 4-H, Barcelona 08007, ES
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
3D-Shaper Medical S.L. (Owner Number: 10087195)
Owner / Operator Contact Address
Rambla Catalunya, 53, 4-H, Barcelona, ES-B 08007, ES
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K220822
PMA Number
N/A

All Registered Proprietary Names

3D-SHAPER 3D-Shaper

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KGI Densitometer, Bone Radiology Class 2 892.1170 2025-12-10
KGI Densitometer, Bone Radiology Class 2 892.1170 2023-01-25

Official Correspondent

Ludovic Humbert

US Agent Details

Mateo Carrasco Business: Carrasco Email: mateo@afpharmaservice.com Phone: (407) 2849480

Related Public Records

Same Entity

3D-Shaper Medical S.L.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K983273 Medical Systems, Inc. XCT 2000 L PQCT BONE DENSITOMETER 1998-10-29

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3026043045. Last updated year: 2026. Please use registration number 3026043045 when referencing this establishment in official correspondence.
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