Organization name

SOFT MEDICAL AESTHETICS

SRN

FR-MF-000009361

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.
• CW001

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

  EUDAMED did not publish a description for this code.
• CW032

  EUDAMED did not publish a description for this code.
• CW009

  EUDAMED did not publish a description for this code.

Primary placement in France; available across 32 countries total.

Trade name

SoftFil® Needle

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.

03760246600729

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-03760246600729

Reference / catalog number

NP2540XL

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 IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 0.5 MU50
• 40 MU50
• XL
• Orange
• 25 A size unit determining the size of the tubes inserted

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

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

• A0101010102HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS

• Class IIa medical devices in EUDAMED

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