IRIX MAX PHOTOSHADE A1-A3.5 DLty L

Organization name

DWS srl

SRN

IT-MF-000013530

Manufacturer status

Active

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

• H317 – May cause an allergic skin reaction.
• H360 – May damage fertility or the unborn child.
• H411 – Toxic to aquatic life with long lasting effects.
• P201 – Obtain special instructions before use.
• P202 – Do not handle until all safety precautions have been read and understood.
• P261 – Avoid breathing dust/fume/gas/mist/vapours/spray.
• P280 – Wear protective gloves/protective clothing/eye protection/face protection.
• P302 – IF ON SKIN: P352 – Wash with plenty of soap and water.
• P333 – If skin irritation or rash occurs: P313 – Get medical advice/attention.
• Do not re-use
• Do not use if package is damaged
• Consult instructions for use
• Contains hazardous substances
• the device should not be used for patients with possible allergy and/or hypersensitivity to methacrylate. A personal medical history including intolerances and allergies has to be taken before treating a patient.The application is to be avoided in: pediatric population, peripubertal males/females, pregnant women and breast-feeding women

  OTHER

Primary placement in Italy; available across 10 countries total.

Trade name

IRIX MAX PHOTOSHADE A1-A3.5 DLty L

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.

08054117261238

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.

805411726-DENTRESTOR-P-BU

Reference / catalog number

10200246

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

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.

• Q010699MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER

• Class IIa medical devices in EUDAMED

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