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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

02041-G — Class IIa MDR by PHYSIOMED ELEKTROMEDIZIN…

MD Atlas
PHYSIOMED ELEKTROMEDIZIN AG

EUDAMED last updated this device on Dec 19, 2024

02041-G

4099649ET_PHYSIODYN98

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: PHYSIOMED ELEKTROMEDIZIN AG
UDI-DI code: 04099649000034
Reference / catalog number: 02041-G

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Manufacturer information

Organization name: PHYSIOMED ELEKTROMEDIZIN AG
SRN: DE-MF-000009637
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 04099649000034
Basic UDI-DI: 4099649ET_PHYSIODYN98
Reference / catalog number: 02041-G
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: PHYSIODYN-Expert is a device intended for delivering of multiple electrotherapy modalities. PHYSIODYN-Expert provides galvanic current, low-frequency currents and medium-frequency currents. Electrical stimulation therapy uses various stimulation currents. These currents differ in their tissue action modes and parameters, such as pulse shape, duration, pause frequency, and intensity.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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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.