Organization name

Zirkonzahn SRL

SRN

IT-MF-000028795

Manufacturer status

Active

D800EXAC00110

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

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

• Consult instructions for use

  Consult electronic instructions for use

• Contains hazardous substances

  Cobalt (Co)

• Do not re-use
• Do not use if package is damaged
• Non-sterile Sterilizable in a steam sterilizer (autoclave) at 132 °C Anticlockwise rotation Clockwise rotation

  OTHER

Primary placement in Italy; available across 32 countries total.

Trade name

LEFT-ROTATING DRILL L31

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.

D800EXAC00110

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.

++D800RescueKitBurDrillFN

Reference / catalog number

EXAC0011

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.

HIBCC

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

https://ifu.zirkonzahn.com/

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.

• Q010599DENTAL INSTRUMENTS, SINGLE-USE - OTHER

• Class IIa medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.

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