Organization name

SIE AG, Surgical Instrument Engineering

SRN

CH-MF-000025018

Manufacturer status

Active

Primary placement in France; available across 32 countries total.

Trade name

LCS InterShields d450 µm

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.

07640167750313

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.

764016775PPACKSKP

Reference / catalog number

510.710.205

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

LCS InterShields d450 µm

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 450 MU43

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

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

• V0599CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER

• Class IIa medical devices in EUDAMED

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