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Wi-3 HAL-RAR Unit

FDA UDIEUDAMED

Class II (US FDA UDI)

by AMI Agency for Medical Innovations GmbH

Identity

Trade Name
Wi-3 HAL-RAR Unit 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 Wi-3 HAL-RAR System. The Wi-3 HAL-RAR System (HAL - Hemorrhoidal Artery Ligation, RAR - Recto Anal Repair) is a Bluetooth-enabled, pulsed Doppler, ultrasound system intended to be used for detecting hemorrhoidal arteries, to manually ligate these arteries (HAL), and subsequently carry out a mucopexy of hemorrhoidal tissue prolapse (RAR) if necessary. FDA UDI
Model / Reference
TRI2010 FDA UDI
Description
Electronic unit for identifying the localised haemorrhoidal arteries by means of acoustic signals. Part of the Wi-3 HAL-RAR System. The Wi-3 HAL-RAR System (HAL - Hemorrhoidal Artery Ligation, RAR - Recto Anal Repair) is a Bluetooth-enabled, pulsed Doppler, ultrasound system intended to be used for detecting hemorrhoidal arteries, to manually ligate these arteries (HAL), and subsequently carry out a mucopexy of hemorrhoidal tissue prolapse (RAR) if necessary. FDA UDI

Identifiers

Catalog Number
TRI2010 FDA UDI
Primary DI / UDI-DI
EAMITRI20100 FDA UDI
FDA Product Code
IYN FDA UDI
FHN FDA UDI
GMDN Term
Noninvasive vascular ultrasound system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1550 FDA UDI
876.4400 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

Yes

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

Dimensions & Sizes

Size
Height — 7 Centimeter FDA UDI
Outer Diameter — 23 Centimeter FDA UDI

Wi-3 HAL-RAR Unit by AMI Agency for Medical Innovations GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
AMI Agency for Medical Innovations GmbH

Sources (2)

  • FDA UDI b5416b5d-7b1f-4218-b480-79326eb07c8e 37 fields · synced Jun 19, 2026
  • EUDAMED 1 fields · synced Jun 2, 2026