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Organization name
UDI-DI code
Reference / catalog number

Macrogol jars — 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 jars

805759247GC04JAK

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: S.I.I.T. srl
UDI-DI code: 08057592470553
Reference / catalog number: GC04D1 GC04D2 GC04E1 GC04E2 GC04E3 GC04E4 GC04F1 GC04F2 GC04I GC04L GC04P1 GC04P2 GC04P3

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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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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 1 country total.

Country	On market since	Until
ItalyPrimary placement		Still on market

Device identification

Trade name: Macrogol jars
UDI-DI code: 08057592470553
Basic UDI-DI: 805759247GC04JAK
Reference / catalog number: GC04D1 GC04D2 GC04E1 GC04E2 GC04E3 GC04E4 GC04F1 GC04F2 GC04I GC04L GC04P1 GC04P2 GC04P3
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: Macrogol is intended for the treatment of occasional and chronic constipation. It is a medical device in powder for oral solution based on macrogol (polyethylene glycol) 3350 or 4000.
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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