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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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SOLUZIONE ENZIMATICA I.S.E. — 3 UDI-DI variants, IVDR

MD Atlas
Biotecnica Instruments S.r.l.

Data from EUDAMED, last updated May 30, 2026

SOLUZIONE ENZIMATICA I.S.E.

803362296243B7

3 UDI-DI variants

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]IVDR Class A

Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class A
Manufacturer: Biotecnica Instruments S.r.l.

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Device characteristics

ReagentProfessional testing

Identity & classification

Basic UDI-DI: 803362296243B7
Device name: SOLUZIONE ENZIMATICA I.S.E.
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class A
Version date: May 25, 2022

Manufacturer & authorised representative

Manufacturer

Name: Biotecnica Instruments S.r.l.
SRN: IT-MF-000008115
Country: Italy
Email: giannini@biotecnica.it

Variants by status

UDI-DI variants

3 UDI-DI variants

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Export results

Applied filters

basicUdiUlid01G3XY93KMS9374GKR4Q48YZTG

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

U1720108033622962854
94508033622962380
947D08033622962434