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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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Dentitex x128 DE / PL / PT / BE / FR… — 1 UDI-DI variant, MDD

MD Atlas
Helago-Pharma GmbH & Co. KG

Data from EUDAMED, last updated May 30, 2026

Dentitex x128 DE / PL / PT / BE / FR / NL / ES

B-34002033006964

1 UDI-DI variant

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

Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class IIb
Manufacturer: Helago-Pharma GmbH & Co. KG

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Device characteristics

No device characteristics flagged

Legacy certificates

Certificate number: D1449500004
Type: refdata.legacy.mdd-certificate-type.ii-excluding-4
Notified body: mdc medical device certification GmbH (0483)
Validity: Dec 31, 2028

Identity & classification

Basic UDI-DI: B-34002033006964
Device name: Dentitex x128 DE / PL / PT / BE / FR / NL / ES
Device model: Dentitex x128 DE / PL / PT / BE / FR / NL / ES
Issuing agency: EUDAMED
Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class IIb
Version date: May 28, 2026

Manufacturer & authorised representative

Manufacturer

Name: Helago-Pharma GmbH & Co. KG
SRN: DE-MF-000004933
Country: Germany
Email: qm@helago.de
Phone: +49 3871 6363 0

Variants by status

UDI-DI variants

1 UDI-DI variant

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Applied filters

basicUdiUlid01KSPGD79VZBYRH3DZ8NQZW0RJ

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

Dentitex x12834002033006964