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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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Helioseal F Plus — 4 UDI-DI variants, MDR (Ivoclar Vivadent AG)

MD Atlas
Ivoclar Vivadent AG

Data from EUDAMED, last updated May 31, 2026

Helioseal F Plus

76152082AFISS001N8

4 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: Ivoclar Vivadent AG

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Device characteristics

No device characteristics flagged

Identity & classification

Basic UDI-DI: 76152082AFISS001N8
Device name: Helioseal F Plus
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Version date: Mar 10, 2026

Manufacturer & authorised representative

Manufacturer

Name: Ivoclar Vivadent AG
SRN: LI-MF-000000522
Country: Liechtenstein
Email: Sandro.Sbicego@ivoclar.com

Variants by status

UDI-DI variants

4 UDI-DI variants

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Applied filters

basicUdiUlid01KKC011QRPNYTWQAD0J4TR0E6

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

Helioseal F Plus Cavifil Refill 50x0.1g07615208294194
Helioseal F Plus Refill 1x1.25g07615208294217
Helioseal F Plus Refill 1x1g07615208294187
Helioseal F Plus Refill 5x1.25g07615208294200