SleeperOne5

Organization name

Dentalhitec

SRN

FR-MF-000003716

Manufacturer status

Active

Primary placement in France; available across 13 countries total.

Trade name

SleeperOne5

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.

03760349809906

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.

B-03760349809906

Reference / catalog number

SO_5B

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

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

Système d’administration d’anesthésique local contrôlée électroniquement.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 850 MU24

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

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

• A020203CARTRIDGE SYRINGES

• Class IIa medical devices in EUDAMED

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