Organization name

DLAB Scientific Co., Ltd.

SRN

CN-MF-000025396

Manufacturer status

Active

4 warnings recorded — scroll inside the panel to see all entries.

• CW273

  To avoid electrical shocks, ensure your hands are dry when touching the power cord
• CW138

  Carefully read all safety messages in this manual and the safety instructions on the PRF Centrifuge
• CW147

  requirements of Protecting from moisture is on the product label.
• CW010

  Consult the instructions for use (IFU) for detailed information

Primary placement in France; available across 28 countries total.

Trade name

DUO Quattro

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.

06975489950006

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.

697548995LJ161AAX8

Reference / catalog number

9143002122

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

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

Status

On the market

Quantity

1

Additional product description

Speed range： 300rpm-4500rpm；Speed/RCF switch, Short-time run function, sound-alert function

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 50–60 MU27
• Maximum capacity 10 ml × 12
• 6 MU29
• （L）303mm×（W）354mm ×（H）323mm

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

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

• B030102APHERESIS PLATELET COLLECTION DEVICES

• Class IIa medical devices in EUDAMED

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