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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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Stomadent Neo — 1 UDI-DI variant, MDD (STOMADENT SK s.r.o.)

MD Atlas
STOMADENT SK s.r.o.

Data from EUDAMED, last updated May 30, 2026

Stomadent Neo

B-85820000433148

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: STOMADENT SK s.r.o.

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Device characteristics

Active device

Legacy certificates

Certificate number: 2019-MDD/QS-054
Type: refdata.legacy.mdd-certificate-type.ii-excluding-4
Notified body: 3EC International a.s. (2265)
Validity: Dec 31, 2028

Identity & classification

Basic UDI-DI: B-85820000433148
Device name: Stomadent Neo
Device model: Dental unit Stomadent
Issuing agency: EUDAMED
Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class IIa
Version date: Apr 25, 2026

Manufacturer & authorised representative

Manufacturer

Name: STOMADENT SK s.r.o.
SRN: SK-MF-000031507
Country: Slovakia
Email: stomadent@stomadent.sk
Phone: +421910406473

Variants by status

UDI-DI variants

1 UDI-DI variant

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Applied filters

basicUdiUlid01KQ1A3SVD5T2GS99CQA6769NS

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

Stomadent NEO85820000433148