Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012032144

FEI Number

3012032144

Entity Name

SMART SOLUTIONS TECHNOLOGIES S.L. (NUUBO)

City/State/Country

madrid Madrid (Province), ES

Establishment Address

P. Castellana n 200, 5 floor Madrid 28046, C/ Velluters 1, nave 5 46980 Paterna (Valencia), madrid Madrid (Province) 28046, ES

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SMART SOLUTIONS TECHNOLOGIES S.L. (Owner Number: 10058748)

Owner / Operator Contact Address

Castellana n 200, 5 Floor, Madrid 28046, C/ Velluters 1, nave 5 46980 Paterna (Valencia), madrid, ES-M 28046, ES

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K173461

PMA Number

N/A

All Registered Proprietary Names

SMART SOLUTIONS TECHNOLOGIES S.L. (NUUBO)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DSH	Recorder, Magnetic Tape, Medical	Cardiovascular	Class 2	870.2800	2018-10-30
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2018-10-30

Official Correspondent

Luis Sanchez Morales

US Agent Details

Nandini Murthy Business: ENEM Consulting, LLC Email: nmurthy@enemconsulting.com Phone: (781) 7105378

Related Public Records

Same Entity

SMART SOLUTIONS TECHNOLOGIES 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
K935043	Siemens Medical Electronics	SIEMENS CLINICAL WORK STATION	1995-04-07
K170948	Acutus Medical, Inc.	AcQMap High Resolution Imaging and Mapping System	2017-10-16
K242016	ABBOTT MEDICAL	EnSite X EP System	2024-08-09
K172182	St. Jude Medical (Now Part of the Abbott Medical)	QUANTIEN Measurement System	2017-08-18
K252013	ABBOTT MEDICAL	EnSite X EP System	2025-09-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2016	Biosense Webster, Inc.	2	Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real-time data on 3-D, color-coded cardiac maps.
Z-0032-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 23 974.
Z-0033-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 633.
Z-0034-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 641
Z-0035-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 658

Similar Registrations

Registration Number	Establishment Name	Location
3014226707	BARDY DIAGNOSTICS, INC.	Bellevue, WA, US
3003584029	Braemar Manufacturing, LLC	San Diego, CA, US
1527715	SCOTTCARE CORPORATION	CLEVELAND, OH, US
3000126629	Philips Electronics Ltd	Mississauga Ontario, CA
3030721635	ICENTIA LLC	Burlington, VT, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012032144. Last updated year: 2026. Please use registration number 3012032144 when referencing this establishment in official correspondence.