Organization name

Protac A/S

SRN

DK-MF-000000963

Manufacturer status

Active

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

Primary placement in Denmark; available across 14 countries total.

Trade name

Protac SenSit Nature set

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.

05714882032251

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.

5714882600AA

Reference / catalog number

600-612-3000-42

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

Protac SenSit Nature set: Puff + chair, back height 78 cm, khaki green. This is a product pack consisting of chair 602 and puff 610.

Additional information URL

https://www.protac.dk/

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.

• Y99DEVICES FOR PERSONS WITH DISABILITIES NOT INCLUDED IN OTHER CATEGORIES - OTHER

• Class I medical devices in EUDAMED