Eu Mdd Eu Md Class 2a On The Market 🇫🇷 France

Transi-Mark

MARQUAT GENIE BIOMEDICAL · 🇫🇷 France
Devices (same UDI-DI)
1
Certificates
1
Countries
1
Notified Bodies
1

Basic Information

Primary DI
03760372870102
Basic UDI-DI Code
B-03760372870102
Reference
C624
Device Types
Single use
Regulation
Eu Mdd
Classification
Eu Md Class 2a
Status
On The Market

Additional Description

Safe and reliable medical device for measuring Colonic Transit Time for patients with chronic constipation or other digestive disorders. Each capsule contains 10 radiopaque markers. Easily identifiable and quantifiable on the X-ray due to their shape, the markers are made of medical grade silicone impregnated with barium sulphate with recognized opacifying properties. These markers are contained in vegetable capsules made of hypromellose which disintegrate in the stomach. They are to be taken orally and will not be digested or metabolized and will pass naturally in the stool.

CND Nomenclature Codes

Code Description
G030703 MARKERS FOR EVALUATION OF GASTROINTESTINAL PASSAGE

Certificates

Type Number
MDD Annex V 9492

Available In Countries

🇫🇷 France

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