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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 Ultra+ — 16 UDI-DI variants, MDR (EnvisionTEC GmbH)

MD Atlas
EnvisionTEC GmbH

Data from EUDAMED, last updated May 23, 2026

Flexcera Smile Ultra+

426068322FLEXCERASMILEU74

16 UDI-DI variants

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

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

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Device characteristics

No device characteristics flagged

Identity & classification

Basic UDI-DI: 426068322FLEXCERASMILEU74
Device name: Flexcera Smile Ultra+
Device model: Flexcera Smile Ultra+
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Version date: Feb 22, 2024

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

16 UDI-DI variants

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Export results

Applied filters

basicUdiUlid01HQ8KTJPKW72PPCZHZJQQ7F8P

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-01-328204260683220737
RES-01-324604260683220676
RES-01-344604260683220881
RES-01-328304260683220744
RES-01-324704260683220683
RES-01-344704260683220898
RES-01-328404260683220751
RES-01-324804260683220690
RES-01-328504260683220768
RES-01-324904260683220706
RES-01-328604260683220775
RES-01-325004260683220713
RES-01-345004260683220904
RES-01-328704260683220782
RES-01-325104260683220720
RES-01-345104260683220874