CALZA 140

Organization name

P.L.U.S. SRL

SRN

IT-MF-000014119

Manufacturer status

Active

Primary placement in Italy; available across 12 countries total.

Trade name

CALZA 140

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.

08001984005205

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.

80340079000000FL

Reference / catalog number

00016

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

Compression tights, 140 denier, providing medium to strong support, with a sheer mesh-knit structure. Equipped with anatomically shaped heel and reinforced toe. Indicated for use in the presence of dilated capillaries and varicose veins. Compression level: 18–22 mmHg (24–29 hPa) Size 5. Colour 36 CHAMOIS.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 5 MU164

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

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

• M030405COMPRESSION STOCKINGS

• Class I medical devices in EUDAMED

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