Organization name

Zirkonzahn SRL

SRN

IT-MF-000028795

Manufacturer status

Active

D800EXAC00210

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

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

• CW010

  Consult electronic instructions for use
• CW265

  Cobalt (Co)
• CW009

  EUDAMED did not publish a description for this code.
• CW007

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

  Non-sterile Sterilizable in a steam sterilizer (autoclave) at 132 °C Anticlockwise rotation Clockwise rotation

Primary placement in Italy; available across 32 countries total.

Trade name

LEFT-ROTATING DRILL L35

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.

D800EXAC00210

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

EXAC0021

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

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

Certificate health across this manufacturer's portfolio.