Organization name

ZARYS International Spółka z ograniczoną odpowiedzialnością

SRN

PL-MF-000000410

Manufacturer status

Active

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

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

TUPFER lux S Gauze balls with X-ray thread, sterile

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.

05904109620754

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.

59079968M02010502-SU6

Reference / catalog number

TK505005-SSXR-P

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

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

5

Additional product description

—

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.

• 05904109620754× 5 unitsBase unit
  • 05904109620761× 50 units

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

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

• M0201050201COTTON GAUZE PADS, WITH X-RAY DETECTABLE THREAD, STERILE

• Class IIa medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.