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Organization name
UDI-DI code
Reference / catalog number

NuuboHome SI_Box_IT — Class IIa MDR by Smart Solutions…

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

EUDAMED last updated this device on May 20, 2026

NuuboHome SI_Box_IT

843657921NuuboHome7C

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: 08436579213138
Reference / catalog number: 5191

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Manufacturer information

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

Critical warnings

6 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
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: NuuboHome SI_Box_IT
UDI-DI code: 08436579213138
Basic UDI-DI: 843657921NuuboHome7C
Reference / catalog number: 5191
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: NuuboHome SI_Box_IT
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z1203020680VITAL 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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Certificates

Certificate health across this manufacturer's portfolio.

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