Eu Mdd Eu Md Class 2b On The Market 🇹🇷 Türkiye

Lithobox

Devices (same UDI-DI)
1
Certificates
1
Countries
6
Notified Bodies
1

Basic Information

Primary DI
D-86800509202003N
Basic UDI-DI Code
B-86800509202003N
Reference
IMPL-700
Device Types
None provided
Regulation
Eu Mdd
Classification
Eu Md Class 2b
Status
On The Market

Additional Description

Recurrent urinary stone disease is one of the oldest known diseases in the history of mankind with bad consequences up to kidney loss. Kidney stone crushing surgeries work on the principle that the electropneumatic ballistic energy applied by the bullet hitting the titanium probe moving with compressed air transfers the force on the kidney stone to the stone and disintegrates it. After the location of the stone is determined with endoscopy systems, the probe is passed through the endoscopy systems and brought into contact with the stone. When the probe touches the stone, the foot pedal is pressed and the shot is fired. It sends the collision energy to the stone with the compressed air created by the bullet in the handpiece and shatters the stone.

CND Nomenclature Codes

Code Description
G030502 LITHOTRIPSY DEVICES

Certificates

Type Number
MDD Annex IV 1984-MDD-20-657

Available In Countries

🇧🇪 Belgium 🇧🇬 Bulgaria 🇩🇪 Germany 🇵🇱 Poland 🇷🇴 Romania 🇹🇷 Türkiye

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