Large Universal Set

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

Panepack

Model / Reference

44000665

Primary DI / UDI-DI

08592323059756

Basic UDI-DI

8592323PANEPACK9A

EMDN Code

T0202 Surgical procedural kits (excluding surgical instrument kits)

Device Class

Class IIb

Medical Purpose

A procedure pack consisting of medical devices and other accessories intended, following sterilization, for the safe performance of both minor outpatient procedures and complex surgical interventions. The packs represent a comprehensive system and, owing to their optimized composition, provide maximum clinical utility. They contain components intended for draping and protecting the surgical field, equipment, healthcare personnel, and the patient, as well as products for preoperative skin disinfection, drying of the surgical wound, subsequent wound dressing, and other items specified by the end user to ensure the safe performance of the surgical procedure. The procedure packs are intended for single use only and are supplied sterile. Instructions for use are provided with each pack. The most critical component included in the pack is classified as a Class IIb medical device.

EUDAMED SRN

CZ-PR-000032922

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  CE/MDR

• Ophthalmic drape 100x100cm, pouch, IF

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  CE/MDR

• Gauze sponges with cotton wool 15x20cm

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  CE/MDR

• COPRI - M Essential

  Class I

  CE/MDR

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