Regenfast 0,6 ml

Organization name

Mastelli S.r.l.

SRN

IT-MF-000023613

Manufacturer status

Active

10 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.
• CW001

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

  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

  Once opened, the product must be used immediately and any residual contents must be discarded
• CW999

  Dispose of the product responsibly after use.

Primary placement in Italy; available across 1 country total.

Trade name

Regenfast 0,6 ml

UDI-DI code

D-8053303260581DDM35GE

Basic UDI-DI

B-8053303260581DDM35GE

Reference / catalog number

DDM35V6C

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

Regenfast 0.6 ml is a viscoelastic, sterile, gel supplied in a pre-filled syringe for single use for dental treatment. Regenfast 0.6 ml contains the association of polynucleotides (10 mg/ml) and hyaluronic acid (10 mg/ml).

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-8053303260581DDM35GE

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

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

• Q0199ODONTOLOGY DEVICES - OTHER