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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

078360 — Class I MDR by Sigma Dental Systems -…

MD Atlas
Sigma Dental Systems - Emasdi GmbH

EUDAMED last updated this device on Nov 27, 2024

078360

426239358001B4

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Sigma Dental Systems - Emasdi GmbH
UDI-DI code: 04262393580019
Reference / catalog number: 078360

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Manufacturer information

Organization name: Sigma Dental Systems - Emasdi GmbH
SRN: DE-MF-000011719
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Jun 9, 2015	Still on market

Device identification

Trade name: not provided
UDI-DI code: 04262393580019
Basic UDI-DI: 426239358001B4
Reference / catalog number: 078360
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: LED Illumination System
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 20 MU50
26 MU50

EMDN nomenclature code(s)

Z12119003COLD LIGHT DENTAL EQUIPMENT

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

078390T plus426239358001B4On the market 078380M plus426239358001B4On the market

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.