Organization name

SMART ALFA TEKNOLOJİ SANAYİ VE TİCARET ANONİM ŞİRKETİ

SRN

TR-MF-000025385

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• Caution

  Consult Instructions for Use

Primary placement in Germany; available across 32 countries total.

Trade name

MSK Go

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.

08683079423530

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.

86830794235MSKBV

Reference / catalog number

MSK

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

‘MSK Go’ is a software as a medical device, designed to assist healthcare professionals in identifying anatomical structures in musculoskeletal (MSK) ultrasound images.

Additional information URL

https://smartalpha.ai/eifu/

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.

• Z11049092VARIOUS ULTRASOUND INSTRUMENTS - MEDICAL DEVICE SOFTWARE

• Class IIa medical devices in EUDAMED

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

Certificate health across this manufacturer's portfolio.