AMI Agency for Medical Innovations GmbH

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Imaging, Pulsed Doppler, Ultrasonic (IYN) (3) Catheter, Pediatric, General & Plastic Surgery (GBN) (2) Electrosurgical, Cutting & Coagulation & Accessories (GEI) (2) Instrument, Ligature Passing And Knot Tying (HCF) (2) Carrier, Ligature (GEJ) (1)

Premarket Exempt

No Yes

Clear

A.M.I. HAL-II Adaptor USA - EAMIAHA0030 Catalog Number : AHA 003

Device Class : 2

Duns Number: 303655286

Premarket Exempt : No

Product Code : IYN

Prescription Use : No

Device Count : 1

A.M.I. HAL-II Electronic System - EAMIAHE2030 Catalog Number : AHE 203

Device Description : Electronic unit for identifying the localised haemorrhoidal arteries by means of 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.

Device Class : 2

Duns Number: 303655286

Premarket Exempt : No

Product Code : IYN

Prescription Use : Yes

Device Count : 1

A.M.I. HAL Handle - EAMIAHH0010 Catalog Number : AHH 001

Device Description : Handle for the HAL/RAR probes.

Device Class : 2

Duns Number: 303655286

Premarket Exempt : No

Product Code : IYN

Prescription Use : Yes

Device Count : 1

A.M.I. HAL Knotpusher - EAMIAHK0070 Catalog Number : AHK 007

Device Description : Knot pusher for placing knots when ligating haemorrhoidal arteries. Part of the Knot pusher for placing knots when ligating haemorrhoidal arteries. Part of the A.M.I. HAL / RAR System.The various Knotpushers are intended for ligature passing and know tying.

Device Class : 1

Duns Number: 303655286

Premarket Exempt : Yes

Product Code : HCF

Prescription Use : Yes

Device Count : 1

A.M.I. HAL Needleholder - EAMIAHN0060 Catalog Number : AHN 006

Device Description : Needle holder for use during haemorrhoidal artery ligation.

Device Class : 1

Duns Number: 303655286

Premarket Exempt : Yes

Product Code : GEJ

Prescription Use : Yes

Device Count : 1

A.M.I. Knotpusher Premium - EAMIAPK0010 Catalog Number : APK 001

Device Description : Knot pusher for placing knots for laparoscopic surgery.The various Knotpushers a Knot pusher for placing knots for laparoscopic surgery.The various Knotpushers are intended for ligature passing and knot tying.

Device Class : 1

Duns Number: 303655286

Premarket Exempt : Yes

Product Code : HCF

Prescription Use : Yes

Device Count : 1

Comfort Drain - EAMICDS20010 Catalog Number : CDS2001

Device Description : The Comfort Drain is a flexible, silicone, elastic drain with knotless closure t The Comfort Drain is a flexible, silicone, elastic drain with knotless closure that facilitates drainage of perianal fistulas.

Device Class :

Duns Number: 303655286

Premarket Exempt : Yes

Product Code : GBN

Prescription Use : Yes

Device Count : 1

Comfort Drain Grasper - EAMICDS20100 Catalog Number : CDS2010

Device Description : For easy closure the Comfort Drain Grasper can be used as a helpful instrument t For easy closure the Comfort Drain Grasper can be used as a helpful instrument to connect the couplingpiece with the cut / trimmed drain during the implantation of a Comfort Drain.

Device Class : 1

Duns Number: 303655286

Premarket Exempt : Yes

Product Code : GBN

Prescription Use : Yes

Device Count : 1

EasyAct Handle - EAMIEAH10100 Catalog Number : EAH1010

Device Class : 2

Duns Number: 303655286

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

EasyAct 3 S - EAMIEAS13100 Catalog Number : EAS1310

Device Class : 2

Duns Number: 303655286

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

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