Organization name

ZARYS International Spółka z ograniczoną odpowiedzialnością

SRN

PL-MF-000000410

Manufacturer status

Active

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

• Do not re-use
• Do not resterilize
• Do not use if package is damaged

Primary placement in Poland; available across 30 countries total.

Trade name

Nelaton Catheter

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.

05907996896011

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.

59079968U010105H9

Reference / catalog number

CC-18-40

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

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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

• 05907996896011× 1 unitBase unit
  • 05907996896028× 10 units
    • 05907996896035× 50 units

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

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

• U01010502NELATON CATHETERS, NON SELF-LUBRICATING

• Class I medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.

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