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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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Flexcera Smile — 6 UDI-DI variants, MDR (EnvisionTEC GmbH)

MD Atlas
EnvisionTEC GmbH

Data from EUDAMED, last updated May 23, 2026

Flexcera Smile

426068322FLEXCERASMILEYJ

6 UDI-DI variants

MDR [Regulation (EU) 2017/745 on medical devices]Class I

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Manufacturer: EnvisionTEC GmbH

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Device characteristics

No device characteristics flagged

Identity & classification

Basic UDI-DI: 426068322FLEXCERASMILEYJ
Device name: Flexcera Smile
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Version date: Nov 19, 2021

Manufacturer & authorised representative

Manufacturer

Name: EnvisionTEC GmbH
SRN: DE-MF-000009311
Country: Germany
Email: info@envisiontec.de
Phone: +49 2043 9875 0

Variants by status

UDI-DI variants

6 UDI-DI variants

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Applied filters

basicUdiUlid01FMW1J043TQ5VTD8TV9A49HF3

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

RES-01-323404260683220522
RES-01-323504260683220539
RES-01-323604260683220546
RES-01-323704260683220553
RES-01-323804260683220560
RES-01-323904260683220577