Condrotide HA

Organization name

Mastelli S.r.l.

SRN

IT-MF-000023613

Manufacturer status

Active

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

• CW275

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

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

  EUDAMED did not publish a description for this code.
• CW267

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

  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.
• CW135

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

  CONDROTIDE HA must not be injected in the presence of an infected or severely inflamed joint. The infiltration should be avoided in case of ongoing infections or inflammations of the skin near the site of the infiltration, so as to prevent the possibility of insurgence of bacterial arthritis.
• CW999

  The use of CONDROTIDE HA is contraindicated in individuals with an individual hypersensitivity to the components of the product or with a positive history of allergy to fish products. The efficacy and safety of CONDROTIDE HA have not been ascertained in pregnant or breast-feeding women, and in children. In this cases treatment with CONDROTIDE HA is not recommended
• CW999

  The use of CONDROTIDE HA is contraindicated in individuals with an individual hypersensitivity to the components of the product or with a positive history of allergy to fish products. The efficacy and safety of CONDROTIDE HA have not been ascertained in pregnant or breast-feeding women, and in children. In this cases treatment with CONDROTIDE HA is not recommended

Primary placement in Italy; available across 1 country total.

Trade name

Condrotide HA

UDI-DI code

D-8053303261465DDM24GX

Basic UDI-DI

B-8053303261465DDM24GX

Reference / catalog number

DDM24BL25XS

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

Condrotide HA is a medical device containing polynucleotides at a concentration of 10mg/ml and sodium hyaluronate at a concentration of 10 mg/ml. Condrotide HA is a sterile, apyrogenic, viscoelastic solution supplied in a pre-filled syringe for single use.

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

D-8053303261465DDM24GX

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

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

• P900402RESORBABLE FILLING AND RECONSTRUCTION DEVICES