Organization name

Magstim Inc.

SRN

US-MF-000024844

Manufacturer status

Active

D-4732020Y8

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

Primary placement in Germany; available across 32 countries total.

Trade name

HCGSN 130

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.

D-4732020Y8

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-4732020Y8

Reference / catalog number

4732020

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.

EUDAMED

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

Hydrocel Geodesic Sensor Nets (HCGSN) 130: 128 ch Adult Medium 56-58 cm

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.

• Z12100303SYSTEMS FOR ANALYSING AND MANAGING EEG TRACES

• Class IIa medical devices in EUDAMED

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