Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Partners 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

Picoblue — Class I MDR by Cometa S.r.l.

MD Atlas
Cometa S.r.l.

EUDAMED last updated this device on Apr 19, 2023

Picoblue

++G082CTPBS58

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Cometa S.r.l.
UDI-DI code: G082CPBS0
Reference / catalog number: Picoblue

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?

View device family (Basic UDI)

Manufacturer information

Organization name: Cometa S.r.l.
SRN: IT-MF-000012630
Manufacturer status: Active

Related devices

EMGMTB-G082EMT0On the market CINSB++G082CINSC2On the market CINSR++G082CINSC2On the market MWB-G082MW0On the market MPBS++G082MWPBS9BOn the market

Certificates

Certificate health across this manufacturer's portfolio.

ITH 1343909 1Amended
Quality management systemNotified body: 1936Expiry: Mar 27, 2028

Critical warnings

2 warnings recorded — scroll inside the panel to see all entries.

CW010
Consultare il manuale utente
CW014
Parte applicata di tipo BF

EasyUDICompliance engine

Sponsored

Your devices, UDI-compliant — without drowning in regulation

EUDAMED-ready· UDI-enriched

Basic UDIUDI-DIUDI-PIAttributeDocument

Print-ready label

From your product file — no manual entry

Exclusive to MD Atlas usersClaim my −20% discount

by Made In Tracker

Market distribution

Primary placement in Italy; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: G082CPBS0
Basic UDI-DI: ++G082CTPBS58
Reference / catalog number: Picoblue
Issuing entity: HIBCC

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: Elettromiografo composto da dei sensori Bluetooth e da una base di ricarica. I sensori rilevano il segnale elettromiografico (EMG) dei muscoli di interesse tramite elettrodi superficiali e inviano i dati ad un PC tramite Bluetooth.
Additional information URL: https://www.cometasystems.com/picoblue/
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Z12062401ELECTROMYOGRAPHIC BIOFEEDBACK SYSTEMS

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

Become a partner of MD Atlas