Exacta Devore Pocket Goniometer

Organization name

North Coast Medical Inc.

SRN

US-MF-000009087

Manufacturer status

Active

Primary placement in Sweden; available across 10 countries total.

Trade name

Exacta Devore Pocket Goniometer

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.

00768627701150

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-1275-RW

Reference / catalog number

NC70115

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

Goniometer, 180 deg. Devore Finger

Additional information URL

https://www.ncmedical.com/products/devore-pocket-goniometer_1275.html?objectID=1275&queryID=00c3eeda762857e892408c7eb1f6b0ae

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.

• Z12069099VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS - OTHER

• Class I medical devices in EUDAMED

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