Oper cat 16 x 5 cm

Organization name

Iberhospitex, S.A.

SRN

ES-MF-000000160

Manufacturer status

Active

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

• Caution

  Residual / Reutilization risks

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

Primary placement in Spain; available across 14 countries total.

Trade name

Oper cat 16 x 5 cm

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.

08428097605908

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.

8428097CATHB

Reference / catalog number

0037447

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

Self-adhesive dressing pouch for the protection of catheters

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 16 MU10
• 5 MU10

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

• 08428097605908× 1 unitBase unit
  • 08428097606028× 25 units
    • 08428097606134× 14 units

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

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

• M0499SPECIAL DRESSINGS - OTHER

• Class I medical devices in EUDAMED

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

Certificate health across this manufacturer's portfolio.