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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

DEXTA CHROMA — Class I MDR by Borea

MD Atlas
Borea

EUDAMED last updated this device on Aug 21, 2024

DEXTA CHROMA

3770024455COBRAVS

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Borea
UDI-DI code: 03770024455120
Reference / catalog number: SF0246

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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: DEXTA CHROMA
UDI-DI code: 03770024455120
Basic UDI-DI: 3770024455COBRAVS
Reference / catalog number: SF0246
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: Main plug input 120 – 240 V / output 5V 1A, Usb type C Calibration tip Reusable / Sterilizable in autoclave (134°C during 20 minutes) Device calibration Automatic calibration at each acquisition Rechargeable battery 3,7 V 1600 mAh Display Color Oled touch screen Measurement time 0.8 seconds Data transfer time 6 seconds Measurement area 1.7 x 1.7 cm Measurement resolution 1 px (Cmos sensor 648x648 px) Software results display 1 shade, 3 parts, 9 parts, detailed mapping, translucency mapping. Shade guide database 6 shade guides availables Digital resolution 128 x 128 Processor IMX8 MM Quad cores 1,8Ghz Dimensions of the handpiece L.185 X w.42 x h 32 (mm) Weight of the hand piece 169 g Dimensions of the docking station L.80 x w.75 x h 55 (mm) Weight of the docking station 124 g Output Wifi 802.11 g
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

Related devices

Cobra3770024455COBRAVSOn the market Rayplicker Cobra3770024455RP_COBRA8JOn the market Rayplicker Handy3770024455RP_HANDY99On 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.