SCLEROJET

Organization name

SAPI MED S.p.A.

SRN

IT-MF-000023733

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.

Primary placement in Italy; available across 12 countries total.

Trade name

SCLEROJET

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.

08033638801918

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.

B-08033638801918

Reference / catalog number

A.5015

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

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

Disposable extension device for haemorrhoidal sclerotherapy.

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.

• G02060399DEVICES FOR COLORECTAL DIAGNOSTIC PROCEDURES - OTHER

• Class I medical devices in EUDAMED

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