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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

Macrogol for colonoscopy — Class IIb MDR by S.I.I.T. srl

MD Atlas
S.I.I.T. srl

EUDAMED last updated this device on May 11, 2026

Macrogol for colonoscopy

805759247GC05EH

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: S.I.I.T. srl
UDI-DI code: 08057592470560
Reference / catalog number: GC05B GC05C GC05D

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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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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 1 country total.

Country	On market since	Until
ItalyPrimary placement		Still on market

Device identification

Trade name: Macrogol for colonoscopy
UDI-DI code: 08057592470560
Basic UDI-DI: 805759247GC05EH
Reference / catalog number: GC05B GC05C GC05D
Issuing entity: GS1

Classification

Risk category: Class IIb
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Medical device intended for bowel cleansing before endoscopic examinations, radiologic examinations or in any clinical or surgical condition requiring a complete cleansing of the gut.
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
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Software identification

EMDN nomenclature code(s)

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

G99GASTROINTESTINAL DEVICES - OTHER

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

Certificate health across this manufacturer's portfolio.

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