-

Organization name

i+Med S.Coop.

SRN

ES-MF-000008633

Manufacturer status

Active

Certificate health across this manufacturer's portfolio.

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

• CW135

  The product should not be administered to children. Keep out of children’s reach.
• CW161

  The product should not be administered to pregnant or breastfeeding women.
• CW999

  Do not administer to patients with known hypersensitivity (allergy) to hyaluronic acid and / or other components of the product. Do not administer to patients with acute or chronic dermatological disorders or an inflammatory and / or infectious type skin problem. Do not administer to patients with coagulation defects and / or who are treated with anticoagulant medication. The producto should not be injected into blood vessels or eyelids; intravascular injection may produce embolization, occlusion of the vessels, ischemia, blindness or infarction. The product should be administered exclusively by intradermal injection following a strict aseptic procedure. The product should be administered with sterile Luer-lock needles (as supplied with the product). It is recommended that the patient do not wear makeup for 12 hours after the injection and avoid prolonged exposure to the sun, to ultraviolet rays, at temperatures below 0°C, as well as the sauna or Turkish bath during two weeks following the injection. The syringe and the used needle should be discarded in a container provided for this purpose.
• CW010

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

  Do not re-sterilize. Re-sterilization can affect the physicochemical properties of the product and compromise its effectiveness and safety.
• CW007

  he product should not be used if the package is damaged or broken.
• CW032

  The product should not be used after the expiration date
• CW276

  Do not use with other products containing quaternary ammonium salts as benzalkonium chloride or with any surgical material treated with this type of substances because sodium hyaluronate can precipitate in their presence
• CW036

  Do not administer in immediate association with laser or pulsed light treatments.

Primary placement in Spain; available across 1 country total.

Trade name

not provided

UDI-DI code

08437027750052

Basic UDI-DI

B-08437027750052

Reference / catalog number

-

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

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 1 MU48

• 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