Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

Rayplicker Cobra — Class I MDR by Borea

MD Atlas
Borea

EUDAMED last updated this device on Oct 27, 2022

Rayplicker Cobra

3770024455RP_COBRA8J

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Borea
UDI-DI code: 03770024455045
Reference / catalog number: RP0201

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

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 Cobra
UDI-DI code: 03770024455045
Basic UDI-DI: 3770024455RP_COBRA8J
Reference / catalog number: RP0201
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 2,4Ah, Micro usb type B 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 DEXTA CHROMA3770024455COBRAVSOn 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.