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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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Organization name
UDI-DI code
Reference / catalog number

PZE — Class IIa MDR by Dampsoft GmbH

MD Atlas
Dampsoft GmbH

EUDAMED last updated this device on Apr 10, 2025

PZE

426237735DSWINHKPuRNQ

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Dampsoft GmbH
UDI-DI code: 04262377350003
Reference / catalog number: PZE

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Manufacturer information

Organization name: Dampsoft GmbH
SRN: DE-MF-000011427
Manufacturer status: Active

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Apr 10, 2025	Still on market

Device identification

Trade name: not provided
UDI-DI code: 04262377350003
Basic UDI-DI: 426237735DSWINHKPuRNQ
Reference / catalog number: PZE
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Bei PZE handelt es sich um eine Software, die vom Hersteller dazu bestimmt ist, die zahnmedizinische Behandlungsplanung anhand des einschlägigen Regelwerks der Versorgungsleitlinien der Kassenzahnärztlichen Bundesvereinigung (KZBV) zu optimieren.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12110192INSTRUMENTS FOR DENTAL TREATMENT UNITS - MEDICAL DEVICE SOFTWARE

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

This device is not currently linked to any other device.

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.