FDA device listing

SMART SOLUTIONS TECHNOLOGIES S.L. (NUUBO)

FDA device listing 1273767448 · SMART SOLUTIONS TECHNOLOGIES S.L.

Key facts

Proprietary names SMART SOLUTIONS TECHNOLOGIES S.L. (NUUBO)
Owner/operator SMART SOLUTIONS TECHNOLOGIES S.L.
Owner/operator number 10058748
Premarket submissions K173461
Product codes DQK, DSH
Device names DQK - Computer, Diagnostic, Programmable, DSH - Recorder, Magnetic Tape, Medical
Device class Class II
Classification regulations (21 CFR) 870.1425, 870.2800
Review panels Cardiovascular
Registered establishments SMART SOLUTIONS TECHNOLOGIES S.L. (NUUBO)
Establishment registrations 3012032144
FEI numbers 3012032144
Establishment operations Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 1–9 UDI devices (GUDID) under the same submission
  • 1–9 Device listings citing the same submission
  • Yes Premarket submission listed

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device listings

Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

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