CER001

Organization name

Dermoaroma Italy srl

SRN

IT-MF-000034895

Manufacturer status

Active

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

• CW007

  EUDAMED did not publish a description for this code.
• CW010

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

  EUDAMED did not publish a description for this code.
• CW011

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

  Warning and precautions: It may happen that sediments appear at the bottom of the container. The possible presence of sediment, when foreseen by the specifications, does not alter the declared performance; avoid contact with eye and mucous membrane; prolonged use may give rise to sensitization. In this case it is recommended to stop the therapy immediately and consult the doctor; after use, do not disperse the product into the environment.; do not use beyond the expiry date indicated on the package; external use; do not swallow; before application, wash your hands thoroughly; particular caution should be paid in the periocular area and in the corners of the mouth; treatment should be carried out at least 48 hours after shaving or waxing; to avoid the onset of allergic reactions, prefer nitrile gloves instead of latex ones. Dry the skin and gloves perfectly between the product applications; the perception of a slight tingling, felt at the first application, must limit the number of passages on the same area, while the perception of intense burning must limit the execution of the procedure itself (expression of irritated skin); the user therefore assumes the sole responsibility for the incorrect and improper use of the product.
• CW999

  Contraindications: Do not use in cases of known sensitivity to the product components; store the vials intact in a cool and dry place at a temperature range of 2 °C – 25 °C away from sunlight; do not swallow, do not inject; for use by healthcare personnel only; in the post-treatment phase, strictly follow the succeeding points: 1. Avoid exposure to the sun and UVA and UVB lamps and in any case always use adequate protection from solar and artificial radiations (Protection factor 50+ according to the COLIPA method). 2. Carry out an extremely delicate cleaning of the treated area, avoiding any type of rubbing during drying. 3. Avoid using pharmaceuticals and/or cosmetic products on your own initiative without first consulting your doctor.
• CW135

  EUDAMED did not publish a description for this code.

Primary placement in Türkiye; available across 1 country total.

Trade name

not provided

UDI-DI code

08056585951840

Basic UDI-DI

B-08056585951840

Reference / catalog number

CER001

Issuing entity

GS1

Risk category

Class IIb

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

5ml vial, 10 units per box

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 5 MU48

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

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

• V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER