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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

035 — Class IIa MDR by Fast Therapies srl

MD Atlas
Fast Therapies srl

EUDAMED last updated this device on Apr 14, 2022

035

805571232ENFPROC9

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Fast Therapies srl
UDI-DI code: 08055712320078
Reference / catalog number: 035

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View device family (Basic UDI)

Manufacturer information

Organization name: Fast Therapies srl
SRN: IT-MF-000022192
Manufacturer status: Active

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048805571232ENFDYNAMIC2ROn the market 002805571232ENFPHYSIOGJOn the market 011805571232ENFSPECIAL3LOn the market 012805571232ENFSPORT2WOn the market 019805571232ENFSTUDIOJNOn the market

Certificates

Certificate health across this manufacturer's portfolio.

IT349045Issued
Quality management systemNotified body: 1370Expiry: Jan 18, 2030

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

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.

Country	On market since	Until
ItalyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08055712320078
Basic UDI-DI: 805571232ENFPROC9
Reference / catalog number: 035
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Dispositivo Medico
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.

Z120601ELECTROTHERAPY EQUIPMENT (INCLUDED TENS)

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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