Organization name

Mercator Medical Spółka Akcyjna

SRN

PL-MF-000018942

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• This product is intended for single use. Do not reuse. Do not use if the packaging has been damaged. Do not use after the expiry date stated on the package label. Do not use if labelling is incomplete or illegible. Components used in gloves production process may cause allergic reactions in some people. Some gloves may contain components known to be a possible cause of allergy for person allergic to them, who may develop contact irritation and/or allergic reaction. In case of an allergic reaction consult a doctor.

  OTHER

Primary placement in Poland; available across 26 countries total.

Trade name

nitrylex basic

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.

05906615029885

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.

5906615RDNSNPF9C

Reference / catalog number

RD30105004_0422

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

dark blue a'100 L

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.

• 05906615029885× 100 unitsBase unit
  • 05906615029939× 10 units

• 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.