Organization name

SARL TOP GLOVES LATEX INDUSTRIES

SRN

DZ-MF-000019176

Manufacturer status

Active

Primary placement in Spain; available across 20 countries total.

Trade name

NITRILE

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.

06134831000152

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.

61348310001NITCL1U9

Reference / catalog number

GN103

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

100

Additional product description

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• LARGE

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

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

• T01020204NITRILE EXAMINATION / TREATMENT GLOVES

• Class I medical devices in EUDAMED

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