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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

Nuubo30 — Class I MDR by Smart Solutions…

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

EUDAMED last updated this device on Sep 7, 2023

Nuubo30

8437011759Nuubo30TP

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Smart Solutions Technologies, S.L. (NUUBO)
UDI-DI code: 08437011759115
Reference / catalog number: 2143

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Manufacturer information

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

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

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

Critical warnings

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

CW007
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.
CW008
use only on intact skin
CW129
Silver

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement		Still on market

Device identification

Trade name: Nuubo30
UDI-DI code: 08437011759115
Basic UDI-DI: 8437011759Nuubo30TP
Reference / catalog number: 2143
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Nuubo30 SII Caja Final Español
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
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Software identification