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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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DEFINISSE — 1 UDI-DI variant, MDD (ASSUT EUROPE SPA)

MD Atlas
ASSUT EUROPE SPA

Data from EUDAMED, last updated May 30, 2026

DEFINISSE

B-08033439173160

1 UDI-DI variant

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

Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class III
Manufacturer: ASSUT EUROPE SPA

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Device characteristics

Implantable

Legacy certificates

Certificate number: EPG-0090-18 Addendum 06-18
Type: refdata.legacy.mdd-certificate-type.ii-4
Notified body: ISTITUTO SUPERIORE DI SANITA' (0373)
Validity: Jan 11, 2023

Certificate number: QCT-0070-18 Addendum 03-18
Type: refdata.legacy.mdd-certificate-type.ii-excluding-4
Notified body: ISTITUTO SUPERIORE DI SANITA' (0373)
Validity: Jan 11, 2023

Identity & classification

Basic UDI-DI: B-08033439173160
Device name: DEFINISSE
Issuing agency: EUDAMED
Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class III
Version date: Feb 27, 2026

Manufacturer & authorised representative

Manufacturer

Name: ASSUT EUROPE SPA
SRN: IT-MF-000018178
Country: Italy
Email: v.dicintio@assuteurope.com
Phone: +39 0863 515000

Variants by status

UDI-DI variants

1 UDI-DI variant

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Applied filters

basicUdiUlid01KJFTCYNMDGKFFJZJSF6JE89W

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

DFB-L-O-B9-03008033439173160