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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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Simple Simon PT — 1 UDI-DI variant, IVDD (Zafena AB)

MD Atlas
Zafena AB

Data from EUDAMED, last updated May 30, 2026

Simple Simon PT

B-07333051101109

1 UDI-DI variant

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]IVDD — General

Legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Risk class: IVDD — General
Manufacturer: Zafena AB

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Device characteristics

ReagentNear-patient testingProfessional testingAnimal tissues / cells

Clinical investigations

Registered: No

Registered: No

Identity & classification

Basic UDI-DI: B-07333051101109
Device name: Simple Simon PT
Issuing agency: EUDAMED
Legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Risk class: IVDD — General
Version date: May 19, 2022

Manufacturer & authorised representative

Manufacturer

Name: Zafena AB
SRN: SE-MF-000024138
Country: Sweden
Email: info@zafena.se
Phone: +4614140520

Variants by status

UDI-DI variants

1 UDI-DI variant

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Applied filters

basicUdiUlid01G3E9PT5F21J2MPR3YB493A2A

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

ZAF-10107333051101109