florio PNH

Organization name

Florio GmbH

SRN

DE-MF-000027001

Manufacturer status

Active

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• CW011

  florio PNH is not intended to be used by patients with a disease other than PNH. Additionally, the patient must not be classified as a minor which is defined as those who have not reached the age of majority within their respective country. florio PNH is not intended to be used in place of advice from a Healthcare Professional (HCP). HCPs are required to exercise independent professional judgement at all times. HCPs are responsible for making decisions related to treatment regimenand would primarily rely on the patient’s individual medical records. Additionally, florio PNH is not an application to be used for reporting side effects of the medicines added and does not store or submit adverse event reports. Please consult your HCP with any questions or concerns you may have regarding your health condition. Relevant contact details of the manufacturer can be found on the manufacturers’ website which should be on any medicine packaging.

Primary placement in Germany; available across 16 countries total.

Trade name

florio PNH

UDI-DI code

04260748180099

Basic UDI-DI

426074818florioPNH49

Reference / catalog number

not applicable

Issuing entity

GS1

Risk category

Class I

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Android variant

Additional information URL

https://florio.com/florio-pnh-instructions-for-use/

Clinical sizes

No clinical sizes registered for this device.

• V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

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• Software identification