ADL Universal Cuff, Medium

Organization name

North Coast Medical Inc.

SRN

US-MF-000009087

Manufacturer status

Active

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

• If cuff feels too tight, skin becomes irritated, or if pain, stiffness, or numbness occur, discontinue use and seek advice from a healthcare professional.

  OTHER

Primary placement in Austria; available across 10 countries total.

Trade name

ADL Universal Cuff, Medium

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.

00768627016797

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.

0768627REHAB-993-HC

Reference / catalog number

NC35338

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

ADL Universal Cuff, Medium

Additional information URL

https://www.ncmedical.com/products/adl-universal-cuff_993.html?objectID=993&queryID=2c2eb903a09af8a3f9c2d6bf1c73f959

Clinical sizes

• 3-1/2" to 4" (8.9 to 10cm)
• Medium

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

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

• Y150999ASSISTIVE EATING AND DRINKING DEVICES - OTHER

• Class I medical devices in EUDAMED

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