11000389

Organization name

Fidia Farmaceutici S.p.A.

SRN

IT-MF-000026988

Manufacturer status

Active

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

• CW010

  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.
• CW009

  EUDAMED did not publish a description for this code.
• CW135

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

  Like any intra-dermal administration, the implantation should not be performed at anatomic sites where infections or inflammatory processes are present.
• CW999

  Do not administer to patients with ascertained individual hypersensitivity to the product components.
• CW999

  Administer using aseptic procedures. Like any percutaneous procedure, the implantation of HYAL SYSTEM is associated with an inherent risk of infection.
• CW999

  When multiple injections are performed to the patient, the needle could be damaged; it is advisable to substitute it with the supplementary needle present in the cardboard box.
• CW999

  The assembled syringe must be discharded immediately after use, regardless of whether or not the solution has been completely administered.

Primary placement in Spain; available across 2 countries total.

Trade name

not provided

UDI-DI code

D-110003894B

Basic UDI-DI

B-110003894B

Reference / catalog number

11000389

Issuing entity

EUDAMED

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

• 1.8%

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

• P900402RESORBABLE FILLING AND RECONSTRUCTION DEVICES