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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

MPBS — Class I MDR by Cometa S.r.l.

MD Atlas
Cometa S.r.l.

EUDAMED last updated this device on Mar 29, 2023

MPBS

++G082MWPBS9B

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Cometa S.r.l.
UDI-DI code: G082MPBS0
Reference / catalog number: MPBS

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View device family (Basic UDI)

Manufacturer information

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

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EMGMTB-G082EMT0On the market CINSB++G082CINSC2On the market CINSR++G082CINSC2On the market MWB-G082MW0On the market Picoblue++G082CTPBS58On 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.

CW014
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.

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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: G082MPBS0
Basic UDI-DI: ++G082MWPBS9B
Reference / catalog number: MPBS
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 4 sensori Bluetooth e da una base di ricarica. I sensori rilevano il segnale elettromiografico (EMG) dei muscoli temporali anteriori e masseteri tramite elettrodi superficiali e inviano i dati ad un PC tramite Bluetooth
Additional information URL: No additional information URL provided by the manufacturer.
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.

Z12100702EMG TELEMETRIC TRANSMITTERS

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

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