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Aci Medical, Inc.

USA · San Marcos

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Singapore, 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

5listed device types

Class I 2Class II 3Class III 0

plus 7 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

1active device licences

Class II 1

2 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

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 States7 registration records, 7 510(k), 0 PMA, 1 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: ACI MEDICAL, LLC · ACI MEDICAL,LLC

FDA 510(k) clearances by year

11985

11986

11988

11990

11991

11996

12014

FDA listed device types

Legging, Compression, Non-Inflatable 1Sleeve, Limb, Compressible 1Plethysmograph, Impedance 1Massager, Therapeutic, Electric 1Binder, Medical, Therapeutic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K131146	ARTASSIST AND VENASSIST	2014-02-10
US	K942530	ART-ASSIST MODEL AA-1000	1996-02-28
US	K903894	VENAPULSE MODELS VP-25 AND VP-50	1991-04-03
CA	28621	ARTASSIST	Class II

Aci 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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