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A.M.I. HAL-II Electronic System

FDA UDI

Class II (US FDA UDI)

by AMI Agency for Medical Innovations GmbH

Identity

Trade Name
A.M.I. HAL-II Electronic System FDA UDI
Generic Name
Noninvasive vascular ultrasound system FDA UDI
Device Name
Electronic unit for identifying the localised haemorrhoidal arteries by means of acoustic signals. Part of the A.M.I. HAL/RAR System. The A.M.I. HAL-II Electronic System is a Doppler-based device. It is powered by a DC voltage source (rechargeable batteries or 12 V adapter). The A.M.I. HAL-II Electronic System generates electrical signals, calculates differences between the wavelength of outgoing and reflected electrical signals, and generates an acoustic Doppler signal. Together with auxiliary A.M.I. devices (A.M.I. HAL Handle, Probe and Sleeve) the A.M.I. HAL-II Electronic System serves for the detection of haemorrhoidal arteries and enables manual ligation of detected arteries, as well as mucopexy of prolapsing haemorrhoidal mucosa. FDA UDI
Model / Reference
AHE 203 FDA UDI
Description
Electronic unit for identifying the localised haemorrhoidal arteries by means of acoustic signals. Part of the A.M.I. HAL/RAR System. The A.M.I. HAL-II Electronic System is a Doppler-based device. It is powered by a DC voltage source (rechargeable batteries or 12 V adapter). The A.M.I. HAL-II Electronic System generates electrical signals, calculates differences between the wavelength of outgoing and reflected electrical signals, and generates an acoustic Doppler signal. Together with auxiliary A.M.I. devices (A.M.I. HAL Handle, Probe and Sleeve) the A.M.I. HAL-II Electronic System serves for the detection of haemorrhoidal arteries and enables manual ligation of detected arteries, as well as mucopexy of prolapsing haemorrhoidal mucosa. FDA UDI

Identifiers

Catalog Number
AHE 203 FDA UDI
Primary DI / UDI-DI
EAMIAHE2030 FDA UDI
510(k) Number
K061831 FDA UDI
FDA Product Code
IYN FDA UDI
GMDN Term
Noninvasive vascular ultrasound system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1550 FDA UDI
Commercial Distribution
Not 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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Weight — 3.2 Kilogram FDA UDI
Depth — 260 Millimeter FDA UDI
Height — 140 Millimeter FDA UDI
Width — 385 Millimeter FDA UDI

A.M.I. HAL-II Electronic System by AMI Agency for Medical Innovations GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K061831 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
AMI Agency for Medical Innovations GmbH

Sources (1)

  • FDA UDI 07f416d1-6060-4d31-8547-444eab3b0894 38 fields · synced May 30, 2026