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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

Rayplicker Handy — Class I MDR by Borea

MD Atlas
Borea

EUDAMED last updated this device on Mar 23, 2022

Rayplicker Handy

3770024455RP_HANDY99

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Borea
UDI-DI code: 03770024455007
Reference / catalog number: RP0001

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Manufacturer information

Organization name: Borea
SRN: FR-MF-000015596
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: Rayplicker Handy
UDI-DI code: 03770024455007
Basic UDI-DI: 3770024455RP_HANDY99
Reference / catalog number: RP0001
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: Dimensions de la pièce à main en mm: L. 210 x L. 75 x H. 155 Poids de la base: 340 g. Dimensions de la base en mm: L. 133 x L. 101 x H. 43 Chargeur: 5V 1Ah Appareil électrique, electroportatif. Usage : Le Rayplicker permet de déterminer la teinte d'une dent par une analyse spectrale de cette dernière. En une seule acquisition, l'utilisateur peut visualiser la nuance de la dent sous différentes cartographies : image polarisée de la dent, une cartographie générale, 3 et 9 zones, une cartographie complète ainsi que la translucidité de la dent. L'appareil dispose d'une tête de mesure optique supprimant les influences de l'environnement extérieur. Son ergonomie permet de scanner toutes les dents, quelle que soit leur position dans la cavité buccale. Caractéristiques des composants ou ingrédients : Capteur Cmos: 400x400 px Spectrophotomètre: plage de mesure de 400-700 nm Batterie Lithium: Li-Po 3,7 V 2200 mAh Caractéristiques des composants ou ingrédients : plasturgie et electronique
Additional information URL: No additional information URL provided by the manufacturer.
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.