Gynecological Set – PGK

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Device Name

Panep Steriset Plus

Model / Reference

42001258

Primary DI / UDI-DI

08592323024495

Basic UDI-DI

8592323PNEPSTERISETPLUS9L

EMDN Code

T0202 Surgical procedural kits (excluding surgical instrument kits)

Device Class

Class IIa

Medical Purpose

A set of medical devices and other accessories intended, after sterilization, for the safe performance of minor outpatient procedures as well as complex surgical interventions. The sets constitute an integrated system and, due to their optimized composition, provide maximum utility value. They include components designed for draping and protecting the surgical field, equipment, medical staff, and the patient, as well as agents for disinfection of the surgical field, drying of the surgical wound and its subsequent dressing, and other items defined by the end user to ensure the safe performance of the surgical procedure itself. The sets are intended for single use and are supplied sterile. The most critical component is classified as risk class IIa.

EUDAMED SRN

CZ-PR-000032922

• Mayo stand cover 80x140 cm, extra reinforced, yellow

  Class I

  CE/MDR

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  Class I

  CE/MDR

• Ophthalmic drape 100x100cm, pouch, IF

  Class I

  CE/MDR

• Gauze sponges with cotton wool 15x20cm

  Class I

  CE/MDR

• COPRI - M Essential

  Class I

  CE/MDR

• Rouška na operační stůl 100x250cm so savou integrovanou absorbční podložkou 60x90cm

  Class I

  CE/MDR

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