Organization name

Vitberg Sikora Jacek

SRN

PL-MF-000010936

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Poland; available across 32 countries total.

Trade name

not provided

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

05904703405948

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

590470340V2RSDE

Reference / catalog number

V3MHAP

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

Vitberg RS model Med Home is a class IIa active therapeutic medical device. The device is intended for active physiotherapy, complex rehabilitation, massage and support of therapeutic processes to increase their effectiveness. The product can be used in hospices, old people's homes, palliative care homes, physical rehabilitation institutions, rest homes, hospitals, sanatoriums, sports clubs, beauty parlours and also at home. Vitberg is intended for post-traumatic rehabilitation, strengthening the musculoskeletal system, alleviating symptoms of diseases (including pain), improving the body's metabolism, circulatory stimulation, tissue relaxation and in preventive action. The operator can be either a layperson or a professional user (medical facility employee). Vitberg is used for approximately 30 minutes of vibratory therapeutic exposure. The device transmits a non-invasive stimulus to the human body via the application surface, which is in direct contact with the patient's body. The apparatus is reusable (disinfection is possible).

Additional information URL

https://www.vitberg.com/

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

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

• Z120616ELECTROMECHANICAL SYSTEMS FOR PHYSICAL THERAPY

• Class IIa medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.