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Medisono

FDA UDI

Class II (US FDA UDI)

by Medisono, LLC

Identity

Trade Name
MEDISONO FDA UDI
Generic Name
Flexible fibreoptic colonoscope FDA UDI
Device Name
Medisono END-VYS EC-430 Colonoscope FDA UDI
Model / Reference
Medisono END-VYS EC-430 Colonoscope FDA UDI
Description
Medisono END-VYS EC-430 Colonoscope FDA UDI

Identifiers

Catalog Number
MES01019 FDA UDI
Primary DI / UDI-DI
B369MES01019 FDA UDI
FDA Product Code
FDF FDA UDI
GMDN Term
Flexible fibreoptic colonoscope FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Flexible fibreoptic colonoscope

Medisono by Medisono, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Flexible fibreoptic colonoscope.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medisono, LLC

Sources (1)

  • FDA UDI b82a23c5-1c0c-4189-bfa3-37664f444e83 35 fields · synced Jun 8, 2026