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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

Nuubo System — Class IIa MDR by Smart Solutions…

MD Atlas
Smart Solutions Technologies, S.L. (NUUBO)

EUDAMED last updated this device on Apr 12, 2023

Nuubo System

8437011759NuuboRECQQ

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Smart Solutions Technologies, S.L. (NUUBO)
UDI-DI code: 08437011759344
Reference / catalog number: 2174

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Manufacturer information

Organization name: Smart Solutions Technologies, S.L. (NUUBO)
SRN: ES-MF-000022284
Manufacturer status: Active

Critical warnings

3 warnings recorded — scroll inside the panel to see all entries.

CW007
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.
CW014
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement		Still on market

Device identification

Trade name: Nuubo System
UDI-DI code: 08437011759344
Basic UDI-DI: 8437011759NuuboRECQQ
Reference / catalog number: 2174
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: NuuboREC Caja Final Italiano
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12030680VITAL SIGNS TELEMETRY INSTRUMENTS - HARDWARE ACCESSORIES
Z12050480HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - HARDWARE ACCESSORIES
Z12059009ECG DATA MANAGEMENT SYSTEMS

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Certificates

Certificate health across this manufacturer's portfolio.

ES25/00000258Issued
Quality management systemNotified body: 1639Expiry: Mar 6, 2030

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On the market