ROS06V

Organization name

Innate s.r.l.

SRN

IT-MF-000026730

Manufacturer status

Active

Certificate health across this manufacturer's portfolio.

6 warnings recorded — scroll inside the panel to see all entries.

• CW010

  EUDAMED did not publish a description for this code.
• CW009

  EUDAMED did not publish a description for this code.
• CW001

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.
• CW032

  EUDAMED did not publish a description for this code.
• CW999

  Is only indicated for intra-dermal injections and must only be dispensed by a doctor who has received specific training on the intra-dermal injection technique. Sensitive skin may be pretreated using a local anesthetic patch or cream. Please note that any anesthesia may cause redness or local hypersensitivity. There are no available clinical data (efficiency, tolerance) about injecting Zhoabex Radiance into an area which has already been treated with another filling product. Patients should be advised not to apply any make-up for 12 hours after the injection and to avoid prolonged exposure to sunlight and UV or using saunas or Turkish baths for one week after the injection. If the needle is blocked, do not increase the pressure on the plunger rod but stop the injection and replace the needle. Do not inject into blood vessels. Do not use it in bones, tendons, ligaments or muscles. Do not inject into naevi. Discard the syringe and remaining product after use. Do not use if packaging has been damaged. The assembled syringe must be discarded immediately after use, regardless of whether or not the solution has been completely administered. After use, dispose according to applicable national practice. For additional information consult instruction for use.

Primary placement in Italy; available across 3 countries total.

Trade name

not provided

UDI-DI code

08051040331199

Basic UDI-DI

B-08051040331199

Reference / catalog number

ROS06V

Issuing entity

GS1

Risk category

Class III

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

Main Ingredients: sodium hyaluronate in concentration of 2,5% and trehalose. It is indicated: in the physiological aging process of the skin, the effects of which include the thickening of the stratum corneum (roughness and reduced brightness of the skin) and alterations of the elastic fibers of the dermis (wrinkles), - in dermal tissue repair process, in cases of scar results following superficial cutaneous trauma (e.g. acne scars and chicken pox)

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.

• P900402RESORBABLE FILLING AND RECONSTRUCTION DEVICES