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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

39192150021 — Class I MDR by Serenity Spa

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Serenity Spa

EUDAMED last updated this device on Feb 16, 2023

39192150021

805815056Ser-HeavyIncoJV

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Serenity Spa
UDI-DI code: 08058150568941
Reference / catalog number: 39192150021

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View device family (Basic UDI)

Manufacturer information

Organization name: Serenity Spa
SRN: IT-MF-000010810
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW009
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Italy; available across 2 countries total.

Country	On market since	Until
ItalyPrimary placement	Jan 1, 2023	Still on market
Belgium	Jan 1, 2023	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08058150568941
Basic UDI-DI: 805815056Ser-HeavyIncoJV
Reference / catalog number: 39192150021
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: 30
Additional product description: Ausilio assorbente fisio-anatomico monouso con barriera ai liquidi, in congiunzione con mezzi di fissaggio integrati, avente forma idonea a realizzare, una volta indossato, una mutandina.
Additional information URL: https://www.serenityshop.it/it/it/index.html
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08058150568941

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

T04010103INCONTINENCE NAPPIES WITH INTEGRATED FIXING SYSTEM

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

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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.