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Amnotec

FDA UDI

Class II (US FDA UDI)

by AMNOTEC International Medical GmbH

Identity

Trade Name
AMNOTEC FDA UDI
Generic Name
Stationary general-purpose fluoroscopic x-ray system, digital FDA UDI
Device Name
VEQTRON ICG/NIR Zoom Objective, f = 14 - 28 mm FDA UDI
Model / Reference
71-089-30 NIR FDA UDI
Description
VEQTRON ICG/NIR Zoom Objective, f = 14 - 28 mm FDA UDI

Identifiers

Catalog Number
71-089-30 NIR FDA UDI
Primary DI / UDI-DI
04250941997044 FDA UDI
FDA Product Code
GCJ FDA UDI
IZI FDA UDI
GMDN Term
Stationary general-purpose fluoroscopic x-ray system, digital FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
892.1600 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

Yes

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

Category: Stationary general-purpose fluoroscopic x-ray system, digital

Amnotec by AMNOTEC International Medical GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Stationary general-purpose fluoroscopic x-ray system, digital.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
AMNOTEC International Medical GmbH

Sources (1)

  • FDA UDI 25c764b5-fd9c-4b8e-a49a-4ae3a3ea0826 34 fields · synced Jun 8, 2026