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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

DPELA19815 — Class IIa MDR by DentalPlus GmbH

MD Atlas
DentalPlus GmbH

EUDAMED last updated this device on Oct 18, 2024

DPELA19815

++D993EldyPlusTX

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: DentalPlus GmbH
UDI-DI code: +D993DPELA198151
Reference / catalog number: DPELA19815

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Manufacturer information

Organization name: DentalPlus GmbH
SRN: DE-MF-000020210
Manufacturer status: Active

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DPPOR29825++D993PolyanPlus73On the market

Market distribution

Primary placement in Germany; available across 2 countries total.

Country	On market since	Until
GermanyPrimary placement	Nov 13, 2019	Dec 31, 2028
Austria	Nov 13, 2019	Dec 31, 2028

Device identification

Trade name: not provided
UDI-DI code: +D993DPELA198151
Basic UDI-DI: ++D993EldyPlusTX
Reference / catalog number: DPELA19815
Issuing entity: HIBCC

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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q010699MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER

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

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.