Basic UDI-DI
Eu Mdr
Eu Md Class 2a
Iriscope Biopsy Procedure Pack
Code: PP10078IRIS.KITCAT33
Devices
2
Certificates
0
Notified Bodies
0
Auth. Representatives
0
Basic Information
- UDI-DI Code
- PP10078IRIS.KITCAT33
- Issuing Agency
- IFA
- Types
- None provided
- Regulation
- Eu Mdr
- Classification
- Eu Md Class 2a
- Last Updated
- April 11, 2025
Medical Purpose
The procedure pack is intended to provide appropriate disposable devices necessary to take a biopsy sample in the lung tracts in combination with the video-endoscopic probe Iriscope, down to peripheral bronchi. The procedure pack must be used during an endoscopic intervention in combination with reusable devices intended to identify the biopsy site. The procedure pack must also be used in the operating channel of a bronchoscope. It includes one guide sheath, one syringe to flush, and one biopsy forceps.
Certificate Health
No certificates associated with this Basic UDI-DI.
Associated Devices
This Basic UDI-DI is associated with 2 devices.
| Name | Status |
|---|---|
| Iriscope Biopsy Procedure Pack | On the market |
| Iriscope Biopsy Procedure Pack | On the market |