Organization name

Major Prodotti Dentari S.p.A.

SRN

IT-MF-000024700

Manufacturer status

Active

No certificate specifically references this device's Basic UDI-DI.

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

• Contains hazardous substances

  Cristobalite, CAS 14464-46-1 - up to 5%

• P260 – Do not breathe dust/fume/gas/mist/vapours/spray.
• P280 – Wear protective gloves/protective clothing/eye protection/face protection.
• Consult instructions for use
• 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.

  OTHER

Primary placement in Italy; available across 32 countries total.

Trade name

ALGILINE - 1x100G

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

08056640084025

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

8056640ALGE9

Reference / catalog number

A8421

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

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

• Class I medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.