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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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Makrogol 3350 balance — 1 UDI-DI variant, MDD (S.I.I.T. srl)

MD Atlas
S.I.I.T. srl

Data from EUDAMED, last updated May 31, 2026

Makrogol 3350 balance

B-060080867G

1 UDI-DI variant

MDD [Directive 93/42/EEC on medical devices]Class IIa

Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class IIa
Manufacturer: S.I.I.T. srl

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Device characteristics

Active device

Legacy certificates

Certificate number: 095-02-06-DM
Type: refdata.legacy.mdd-certificate-type.v
Notified body: ITALCERT SRL (0426)
Validity: Nov 20, 2023

Identity & classification

Basic UDI-DI: B-060080867G
Device name: Makrogol 3350 balance
Issuing agency: EUDAMED
Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class IIa
Version date: Feb 16, 2025

Manufacturer & authorised representative

Manufacturer

Name: S.I.I.T. srl
SRN: IT-MF-000022188
Country: Italy
Email: surveillance@siit-it.com
Phone: +02 4843521

Variants by status

UDI-DI variants

1 UDI-DI variant

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basicUdiUlid01JM84E07KF8Q1PJ1VZ0Y1EGV0

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

2659655D-060080867G