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ROCKET USA - A&A MEDICAL, INC.

USA · Alpharetta

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, Israel — 4 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

16listed device types

Class I 4Class II 12Class III 0

plus 16 registration records and 19 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

5registered devices

Class I 1Class II 4

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

5active device licences

Class II 5

17 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States16 registration records, 19 510(k), 0 PMA, 1 excluded

Brazil5 confirmed, 0 excluded

Canada5 confirmed, 1 excluded

Manufacturer names merged into this page: ROCKET MEDICAL PLC · ROCKET USA - A&A MEDICAL, INC.

FDA 510(k) clearances by year

11996

11997

21998

62000

12003

22004

12005

12013

22016

12017

12021

FDA listed device types

showing 8 of 16

Needle, Assisted Reproduction 1Chest Drainage Kit 1Catheter, Assisted Reproduction 1Cannula, Intrauterine Insemination 1System, Imaging, Pulsed Echo, Ultrasonic 1Electrode, Circular (Spiral), Scalp And Applicator 1Apparatus, Suction, Patient Care 1Bottle, Collection, Vacuum 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K210509	Rocket Platinum Cured Cathter	2021-09-09
US	K163321	Rocket Indwelling Pleural Catheter (IPC) Insertion Kit	2017-08-17
US	K162457	Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit	2016-11-14
BR	80807430013	Cateter Ureteral Piscante Duplo J Rabo de Porco	Class II
BR	80807430047	Garrafa Única Rocket	Class II
BR	80807430046	Acoplador de guia leve Rocket® Uriglow®	Class I
CA	3287	EMBRYON SOFT GIFT CATHETER	Class II
CA	3288	HULKA CLEMENS FALLOPIAN TUBE CLIP	Class II
CA	3292	CRAFT PUSH-ON TUBING SET	Class II

ROCKET USA - A&A MEDICAL, INC.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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