Total C-ram

Organization name

ITENA CLINICAL

SRN

FR-MF-000011957

Manufacturer status

Active

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

• CW007

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

  Unpolymerized methacrylate-based resin may cause contact dermatitis and damage the pulp. Avoid contact with skin, eyes, and soft tissues. In case of contact, rinse thoroughly with water.
• CW999

  Automix tips are for single use only
• CW999

  Do not use after expiration date.

Primary placement in France; available across 13 countries total.

Trade name

Total C-ram

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.

03760260221245

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.

B-03760260221245

Reference / catalog number

TTCRAM-BLC

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 IIa

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

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.

• Q0101010299TEMPORARY AND PERMANENT DENTAL RESTORATION CEMENTS - OTHER

• Class IIa medical devices in EUDAMED

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