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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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DENTIX E — 1 UDI-DI variant, MDD (SKYDENT, a.s.)

MD Atlas
SKYDENT, a.s.

Data from EUDAMED, last updated May 31, 2026

DENTIX E

B-08588003514707

1 UDI-DI variant

MDD [Directive 93/42/EEC on medical devices]Class IIa

Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class IIa
Manufacturer: SKYDENT, a.s.

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Device characteristics

No device characteristics flagged

Legacy certificates

Certificate number: 2020-MDD/QS-057
Type: refdata.legacy.mdd-certificate-type.ii-excluding-4
Notified body: 3EC International a.s. (2265)
Validity: May 26, 2024

Identity & classification

Basic UDI-DI: B-08588003514707
Device name: DENTIX E
Issuing agency: EUDAMED
Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class IIa
Version date: May 21, 2026

Manufacturer & authorised representative

Manufacturer

Name: SKYDENT, a.s.
SRN: SK-MF-000044434
Country: Slovakia
Email: skydent@skydent.sk

Variants by status

UDI-DI variants

1 UDI-DI variant

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basicUdiUlid01KS4Y52PM8WA00TX1869K8ZP6

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

5147008588003514707