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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 11, 2023

Nuubo System

8437011759NuuboLEONARDOQ2

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: 08437011759412
Reference / catalog number: 2181

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Manufacturer information

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

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW007
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: 08437011759412
Basic UDI-DI: 8437011759NuuboLEONARDOQ2
Reference / catalog number: 2181
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: Leonardo 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)

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

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

Related devices

Nubo308437011759Nuubo30TPOn the market Nuubo Leonardo Final Box Italian8437011759NuuboDSXBOn the market Nuubo Leonardo Final Box Portuguese8437011759NuuboDSXBOn the market Nuubo Leonardo Final Box Spanish8437011759NuuboDSXBOn the market Nuubo REC8437011759NuuboDSXBOn the market

Certificates

Certificate health across this manufacturer's portfolio.

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