Organization name

GPI S.P.A.

SRN

IT-MF-000020127

Manufacturer status

Active

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

• CW011

  The Emolife product is a medical device. Follow the instructions in the user manual carefully to allow the reliability and safety of the medical device software during use. It is necessary to use the product appropriately always observing all warnings so that perfect operation is guaranteed. Improper use may compromise data security. The use of the medical device software is intended for properly trained users only. The software cannot be used as the sole source of clinical decision making. All maintenance activities of the medical device must be carried out by competent and appropriately trained personnel. An incorrect installation of the device can lead to the malfunction of the entire system, so remember to carefully follow the instructions below and use the device only after testing. Use only HW compatible with the indicated characteristics.

Primary placement in Italy; available across 17 countries total.

Trade name

not provided

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.

80589461100888

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.

805894611EMOLIFE10MS

Reference / catalog number

EMOLIFE / E-DELPHYN MD

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 IIb

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

https://istruzioni-mediche.gpi.it/emolife

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.

• Z121799BLOOD TRANSFUSION INSTRUMENTS - OTHER

• Class IIb medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.