Organization name

AFEA S.R.L.

SRN

IT-MF-000044680

Manufacturer status

Active

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

• Consult instructions for use

Primary placement in Italy; available across 32 countries total.

Trade name

H2O CCE

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.

08057808170000

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.

805780817-H2O+CCE-AZ

Reference / catalog number

H2O CCE

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

Drug Therapy Management: facilitates the prescription, administration, and logistical management of medications, including real-time availability checks during the prescribing and administration phases by monitoring consumption and movement. It manages pharmacotherapy, antiblastic therapies, and oncological protocols. Furthermore, it supports medical and pharmaceutical staff in defining and entering complex protocols and dose calibration, enabling the preparation and traceability of bags within the UMACA (Antiblastic Chemotherapy Compounding Unit). Clinical Documentation Management: centralizes and organizes clinical documentation, supporting healthcare professionals in score collection and the interpretation of data useful for guiding clinical decisions. Monitoring and Diagnostic Support: acquires and processes clinical parameters and laboratory results, providing crucial information for patient monitoring and as a support for the diagnostic decisions of healthcare providers. In order to perform these functions, H2O CCE integrates clinical guidelines, therapeutic protocols, and validated PDTAs (Diagnostic-Therapeutic-Care Pathways).

Additional information URL

No additional information URL provided by the manufacturer.

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.

• V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

• Class IIb medical devices in EUDAMED

This device is not currently linked to any other device.

Certificate health across this manufacturer's portfolio.