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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

301 — Class IIa MDR by SOPLAST EMILIANA S.r.l.

MD Atlas
SOPLAST EMILIANA S.r.l.

EUDAMED last updated this device on Feb 20, 2026

301

805214119DMClasse2afarm6P

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SOPLAST EMILIANA S.r.l.
UDI-DI code: 08052141190050
Reference / catalog number: 301

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View device family (Basic UDI)

Manufacturer information

Organization name: SOPLAST EMILIANA S.r.l.
SRN: IT-MF-000025628
Manufacturer status: Active

Related devices

620805214119DMClasse2a3ZOn the market 201805214119DMClasse2afarm6POn the market 202805214119DMClasse2afarm6POn the market 302805214119DMClasse2a3ZOn the market 501805214119DMClasse2a3ZOn the market

Certificates

Certificate health across this manufacturer's portfolio.

62182Issued
Quality assuranceNotified body: 0546Expiry: Jan 20, 2031

Critical warnings

2 warnings recorded — scroll inside the panel to see all entries.

CW009
EUDAMED did not publish a description for this code.
CW007
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: 08052141190050
Basic UDI-DI: 805214119DMClasse2afarm6P
Reference / catalog number: 301
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: 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)08052141190050

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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.

R03010380AEROSOL THERAPY SYSTEMS - ACCESSORIES

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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