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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

SMASKR-002XL — Class IIa MDR by Intersurgical SpA

MD Atlas
Intersurgical SpA

EUDAMED last updated this device on May 26, 2026

SMASKR-002XL

80583230DCSMASKRVE

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Intersurgical SpA
UDI-DI code: 08058323040939
Reference / catalog number: SMASKR-002XL

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View device family (Basic UDI)

Manufacturer information

Organization name: Intersurgical SpA
SRN: IT-MF-000010729
Manufacturer status: Active

Related devices

CA022M/2R80583230DCCASCHIKDOn the market CP92280583230DCACCESSORI_IIaDKOn the market CP92680583230DCACCESSORI_IIaDKOn the market CP143080583230DCUSTOMVENT5GOn the market CP78780583230DCUSTOMVENT5GOn the market

Certificates

Certificate health across this manufacturer's portfolio.

ITH 1344699 1Supplemented
Quality management systemNotified body: 1936Expiry: Jan 24, 2028

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.

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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: not provided
UDI-DI code: 08058323040939
Basic UDI-DI: 80583230DCSMASKRVE
Reference / catalog number: SMASKR-002XL
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: XL

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08058323040939

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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.

R0301010202NIV MASKS

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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