Organization name

DeepHealth, Inc.

SRN

US-MF-000051664

Manufacturer status

Active

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

• CW999

  Contraindication - TechLive is not intended for primary interpretation or patient diagnosis.

Primary placement in Germany; available across 25 countries total.

Trade name

TechLive

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.

00860005144044

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.

08600051440TL1LB

Reference / catalog number

V.1.x.y

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 I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

TechLive is a software application intended to provide remote access for real-time image acquisition, assistance, review, monitoring and standardization of imaging devices across multiple locations. It is a vendor neutral solution allowing read-only or full access control to connected devices. TechLive is also intended for training of medical personnel working on medical imaging devices. TechLive is not intended for diagnostic use.

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.

• Z119092VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - MEDICAL DEVICE SOFTWARE

• Class I medical devices in EUDAMED

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

Certificate health across this manufacturer's portfolio.