Organization name

Saeg srl

SRN

IT-MF-000022747

Manufacturer status

Active

Primary placement in Italy; available across 32 countries total.

Trade name

Fresa carotatrice

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.

08053610298758

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.

805361029FRECAR8S

Reference / catalog number

FCR-300

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

https://saeg.it/wp-content/uploads/2023/06/Istruzioni_frese.pdf

Clinical sizes

• 3,00mm

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• L149009ENT SURGERY BURS, REUSABLE

• Class IIa medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.

• 0425-MDR-030024-01Issued
  Quality management systemNotified body: ICIM S.P.A. (0425)Expiry: May 7, 2028