A8418

Organization name

Major Prodotti Dentari S.p.A.

SRN

IT-MF-000024700

Manufacturer status

Active

Certificate health across this manufacturer's portfolio.

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

• CW010

  EUDAMED did not publish a description for this code.
• CW265

  Cristobalite, CAS 14464-64-1 - up to 5%
• CW158

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

  In case of allergy to one of the components, irritation, redness, or signs of hypersensitivity may occur. Before using, a possible existing allergy potential of the patient should be clarified as well as an allergic reaction to the current product components in the past. In these cases, the product must not be used. After removal of the impression, ask the patient to rinse well his mouth and check for any possible residuals left. Taking multiple impressions of the same jaw (more than 3 or 4 in the same session) can cause mucosal irritation.

Primary placement in Spain; available across 32 countries total.

Trade name

not provided

UDI-DI code

08056640084001

Basic UDI-DI

8056640ALGE9

Reference / catalog number

A8418

Issuing entity

GS1

Risk category

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 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

No clinical sizes registered for this device.

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

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

• Q01020101DENTAL IMPRESSION ALGINATES