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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

1541 — Class I MDR by Sisma S.p.A.

MD Atlas
Sisma S.p.A.

EUDAMED last updated this device on May 27, 2026

1541

8003350SEM9000EE

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Sisma S.p.A.
UDI-DI code: 08003350545391
Reference / catalog number: 1541

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View device family (Basic UDI)

Manufacturer information

Organization name: Sisma S.p.A.
SRN: IT-MF-000038326
Manufacturer status: Active

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1506AES8003350SEM4000DBOn the market 1541AES8003350SEM9000EEOn the market 1527BENNET8003350SEM4000DBOn the market 1520/BENNET8003350SEM4000DBOn the market 1541BENNET8003350SEM9000EEOn 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

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

CW999
To be used after washing hands. To be used on superficial wounds only. Single use device, do not reuse: possible infections and failure of functionality. Contact the manufacturer, should any accidents occur when using the product. Do not use if the package is damaged. Keep out of reach of children.

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Market distribution

Primary placement in Italy; available across 2 countries total.

Country	On market since	Until
ItalyPrimary placement	Jul 21, 2015	Still on market
Malta		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08003350545391
Basic UDI-DI: 8003350SEM9000EE
Reference / catalog number: 1541
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

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

M010101HYDROPHILIC COTTON

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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