A.M.I. HAL Handle

FDA UDI

Class II (US FDA UDI)

by AMI Agency for Medical Innovations GmbH

Identity

Trade Name: A.M.I. HAL Handle FDA UDI
Generic Name: Noninvasive vascular ultrasound system FDA UDI
Device Name: Handle for the HAL/RAR probes. FDA UDI
Model / Reference: AHH 001 FDA UDI
Description: Handle for the HAL/RAR probes. FDA UDI

Identifiers

Catalog Number: AHH 001 FDA UDI
Primary DI / UDI-DI: EAMIAHH0010 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: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Noninvasive vascular ultrasound system

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

Similar devices

Also classified as Noninvasive vascular ultrasound system.

Summit Doppler — CooperSurgical, Inc. · Class II
Summit Doppler — CooperSurgical, Inc. · Class II
DigiDop — Newman Medical · Class II
NovaGuide™ Intelligent Ultrasound System — Novasignal Corporation · Class II
Vave — VAVE HEALTH INC · Class II
TRIA II Display Doppler — CooperSurgical, Inc. · Class II
Summit Doppler — CooperSurgical, Inc. · Class II
DigiDop — Newman Medical · Class II

Cleared under the same submission

K061831 also covers:

RAR Flexi Probe — AMI Agency for Medical Innovations GmbH

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: AMI Agency for Medical Innovations GmbH

Sources (1)

FDA UDI e1c05905-b807-4e76-a538-1150e1a77684 35 fields · synced May 30, 2026