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ARMM, INC.

USA · Huntington Beach

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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

40listed device types

Class I 16Class II 21Class III 3

plus 44 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

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

3active device licences

Class II 3

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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 States44 registration records, 4 510(k), 0 PMA

Brazil1 confirmed, 0 excluded

Canada3 confirmed, 0 excluded

Manufacturer names merged into this page: ARMM, INC. · ARMM INC.

FDA 510(k) clearances by year

31993 · K923201

11998 · K981286

FDA listed device types

showing 8 of 40

Instruments, Dental Hand 1Bur, Surgical, General & Plastic Surgery 1Catheter, Pediatric, General & Plastic Surgery 1Device, Irrigation, Ocular Surgery 1Accessories, Arthroscopic 1Accessories, Catheter 1Stabilizer, Heart 1Instrument, Manual, Surgical, General Use 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K981286	SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETS	1998-06-19
US	K923201	ENDOSI SUCTION IRRIGATOR	1993-09-23
US	K922245	SUPER-FLOW TUBING	1993-09-03
BR	10355870162	SINUS LIFT BALLOON	Class II
CA	14130	ENDOSI SUCTION IRRIGATION DEVICES AND SUPERFLOW TUBING SETS	Class II
CA	14131	WOUND DRAINS	Class II
CA	82231	SINUS LIFT BALLOON	Class II

ARMM, 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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