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Nuubo30

by Smart Solutions Technologies, S.L. (NUUBO) 3 variants

Ref 2020Model Nuubo30

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, self-declared

Class I: no certifier involved

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 Number8437011759Nuubo30TP Basic UDI-DI 08437011759016UDI-DIDate7 Sep 2023RegisteredStatusActive EUDAMED: not on the EU market
United StatesGUDID listing GUDID Number08437011759016 UDI-DI Date15 Nov 2019ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

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  • Withdrawn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

Trade Name
Nuubo30 EUDAMED
Nuubo System GUDID
Generic Name
Electrocardiographic lead set, single-use
Model / Ref / Catalog
Nuubo30, 2020
Description
Nuubo30 SI Box USA. Textile with an integrated electrodes technology for sensing the patient’s ECG.
Primary DI / UDI-DI
08437011759016
Basic UDI-DI
8437011759Nuubo30TP
Direct Marketing DI
08437011759016
510(k) Number
FDA Product Code
DSH
EMDN Code
Z12030680, Z12050480, Z12059009
GMDN Term
Electrocardiographic lead set, single-use
Device Class
Class I 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 I
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

  • Single Use
  • Incorporates Medicinal Product
  • Over-the-Counter
  • Combination Product
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • Sterile: 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
  • Measuring Function: No
  • Prescription Use: No
  • Convenience Kit: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No