Organization name

Nonin Medical, Inc.

SRN

US-MF-000008228

Manufacturer status

Active

Primary placement in Netherlands; available across 18 countries total.

Trade name

Multi-Parameter Finger Clip Sensor

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.

00849686065886

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-00849686065886

Reference / catalog number

112280-001

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 IIb

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

MODEL 8330AA, Co-MET REUSABLE FINGER CLIP SENSOR

Additional information URL

No additional information URL provided by the manufacturer.

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.

• C900301PULSE OXIMETER SENSORS

• Class IIb medical devices in EUDAMED

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