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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

ARC FACIAL — Class I MDR by Fabrications…

MD Atlas
Fabrications automatiques Gerbelot

EUDAMED last updated this device on Jun 24, 2025

ARC FACIAL

376042758ARCFACIAL8R

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Fabrications automatiques Gerbelot
UDI-DI code: 03760427580017
Reference / catalog number: AF200

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Manufacturer information

Organization name: Fabrications automatiques Gerbelot
SRN: FR-MF-000026383
Manufacturer status: Active

Market distribution

Primary placement in France; available across 1 country total.

Placed on the market in France; per-country availability dates not published.

Device identification

Trade name: ARC FACIAL
UDI-DI code: 03760427580017
Basic UDI-DI: 376042758ARCFACIAL8R
Reference / catalog number: AF200
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: Permet d'enregistrer la position des maxillaires du patient par rapport à un plan de référence.
Additional information URL: https://www.fag-dentaire.com/wp-content/uploads/2022/05/arc-facial-2022-notice-2.pdf
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q0199ODONTOLOGY 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

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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.