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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

Nubo30 — Class I MDR by Smart Solutions…

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

EUDAMED last updated this device on Sep 7, 2023

Nubo30

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: 08437011759108
Reference / catalog number: 2142

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Manufacturer information

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

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: Nubo30
UDI-DI code: 08437011759108
Basic UDI-DI: 8437011759Nuubo30TP
Reference / catalog number: 2142
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 SI 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
Serial number
Software identification

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