Organization name

Mosaic Surgical Ltd

SRN

GB-MF-000003512

Manufacturer status

Active

Primary placement in XI; available across 32 countries total.

Trade name

Galaxy II

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.

15060557440102

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-15060557440102

Reference / catalog number

JUNE3001B5

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

Galaxy II Square Pack (5mm Blunt)

Additional information URL

https://junemedical.com/galaxy-ii-overview/literature/

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.

• L03140101SELF-STATIC SPREADERS, REUSABLE

• Class IIa medical devices in EUDAMED

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