Dx-Sleep Adapter

Organization name

Respiratory Technology Corporation

SRN

US-MF-000009086

Manufacturer status

Active

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

• Consult healthcare professional before use

  Consult healthcare professional before use, Physician Only Administered

Primary placement in Poland; available across 10 countries total.

Trade name

Dx-Sleep Adapter

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.

00899994002172

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-00899994002172

Reference / catalog number

Dx-400

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

1/8" Mono male audio jack output. For connecting Dx-Recorder to PSG header box

Additional information URL

https://www.restech.com/physician-content/

Clinical sizes

• 1 MU169

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• G030702PH MONITORING DEVICES

• Class IIa medical devices in EUDAMED

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