Skip to content

Nuubo System

by Smart Solutions Technologies, S.L. (NUUBO) 2 variants

Ref 2140Model NuuboREC

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8437011759NuuboRECQQ Basic UDI-DI 08437011759078UDI-DIDate11 Apr 2023RegisteredStatusActive EUDAMED: not on the EU market
United StatesGUDID listing GUDID Number08437011759078 UDI-DI Date19 Nov 2019ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Electrocardiographic ambulatory recorder
Model / Ref / Catalog
NuuboREC, 2140
Primary DI / UDI-DI
08437011759078
Basic UDI-DI
8437011759NuuboRECQQ
Direct Marketing DI
08437011759078
510(k) Number
FDA Product Code
DSH
EMDN Code
Z12030680, Z12050480, Z12059009
GMDN Term
Electrocardiographic ambulatory recorder
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.2800
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
ES-MF-000022284

Other devices from Smart Solutions Technologies, S.L. (NUUBO)

See all devices from Smart Solutions Technologies, S.L. (NUUBO) →

Properties

  • Measuring Function
  • Over-the-Counter
  • Combination Product
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (18)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Convenience Kit: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No