380800000301

Organization name

NOVAVISION GROUP

SRN

IT-MF-000024333

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 Italy; available across 11 countries total.

Trade name

not provided

UDI-DI code

08059340930098

Basic UDI-DI

805934093N00994V

Reference / catalog number

380800000301

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

The 4Plus equipment is a radiofrequency generator indicated for non-invasive application in procedures for the treatment of: edematous-fibrosclerotic panniculopathy (pathology caused by an alteration of the subcutaneous tissue or hypodermis with hypertrophy of fat cells); vaginal laxity (it improves the elasticity and firmness of the vaginal canal by stimulating the production of collagen and elastin); vulvo-vaginal atrophy (it stimulates cell generation while reducing symptoms of vulvo-vaginal atrophy such as dryness, itching and pain from intercourse); mild stress urinary incontinence (it restores the pelvic floor function by reducing urinary leakage).

Additional information URL

No additional information URL provided by the manufacturer.

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.

• Z12040203DERMAL REGENERATION EQUIPMENT