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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

06008085 — Class IIa MDD by S.I.I.T. srl

MD Atlas
S.I.I.T. srl

EUDAMED last updated this device on Mar 13, 2026

06008085

B-ESPUMIP5

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: S.I.I.T. srl
UDI-DI code: D-ESPUMIP5
Reference / catalog number: 06008085

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View device family (Basic UDI)

Manufacturer information

Organization name: S.I.I.T. srl
SRN: IT-MF-000022188
Manufacturer status: Active

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OC01B - Hypertonic solutionB-060084907TOn the market OC10A - Throat sprayB-060086147MOn the market OC05BB-060089478KOn the market BC21 (Bottle 30 mL)B-060075297NOn the market OC01A - Mild hypertonic solutionB-060062867COn the market

Certificates

Certificate health across this manufacturer's portfolio.

065-00-01-MDRSupplemented
Quality management systemNotified body: 0426Expiry: Nov 20, 2029

Critical warnings

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

CW010
.

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Market distribution

Primary placement in Italy; available across 2 countries total.

Country	On market since	Until
ItalyPrimary placement	Apr 22, 2020	Still on market
Germany	Apr 22, 2020	Still on market

Device identification

Trade name: not provided
UDI-DI code: D-ESPUMIP5
Basic UDI-DI: B-ESPUMIP5
Reference / catalog number: 06008085
Issuing entity: EUDAMED

Classification

Risk category: Class IIa
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Medical device indicated in the treatment in case of: dyspeptic disorders, gastroenteric meteorism, aerophagy and gas colic in infants, children and adults
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.

G0401ORALLY ADMINISTERED DEVICES FOR THE THERAPY OF GASTRO-INTESTINAL DISORDERS

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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