Organization name

Roncadelle Operations Srl

SRN

IT-MF-000017979

Manufacturer status

Active

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

• Caution
• Consult instructions for use
• Do not re-use
• Do not resterilize
• Do not use if package is damaged

Primary placement in Italy; available across 16 countries total.

Trade name

SafeR Syringe

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.

08056999020040

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.

805699902SyringeCP00201F9

Reference / catalog number

SFS0500

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

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

Status

On the market

Quantity

1

Additional product description

Safety Syringe 5 ml

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

1 packaging level registered — each level carries its own UDI-DI.

• 08056999020040× 1 unitBase unit
  • 18056999020047× 100 units

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

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

• A02010205INFUSION AND IRRIGATION SYRINGES WITH SAFETY SYSTEM, SINGLE-USE

• Class I medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.

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