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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

878K.314.021 — Class IIa MDR by Edenta Etablissement

MD Atlas
Edenta Etablissement

EUDAMED last updated this device on Feb 2, 2022

878K.314.021

++E31216670EL

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Edenta Etablissement
UDI-DI code: E312878K3140211
Reference / catalog number: 878K.314.021

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View device family (Basic UDI)

Manufacturer information

Organization name: Edenta Etablissement
SRN: LI-MF-000011937
Manufacturer status: Active

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Certificates

Certificate health across this manufacturer's portfolio.

1000183128Issued
Quality management systemNotified body: 0297Expiry: Mar 26, 2030

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Liechtenstein; available across 1 country total.

Country	On market since	Until
LiechtensteinPrimary placement	Dec 1, 2022	Still on market

Device identification

Trade name: not provided
UDI-DI code: E312878K3140211
Basic UDI-DI: ++E31216670EL
Reference / catalog number: 878K.314.021
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: 5
Additional product description: —
Additional information URL: https://www.edenta.com/
Clinical sizes: 2.1 MU50

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

E312878K3140211

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Z12110102DENTAL DRILLS

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

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