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Arteriocyte Medical Systems, Inc.

USA · Hopkinton

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Canada, Taiwan, Singapore, Australia, Israel — 6 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

10listed device types

Class I 4Class II 6Class III 0

plus 16 registration records and 1 510(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 III 1

3 including historic records

TWTaiwanTFDA

2valid device licences

Class II 2

SGSingaporeHSA SMDR

3device registrations

CLASS B 3

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

4active ARTG entries

IIa 4

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

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, 1 510(k), 0 PMA

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: Arteriocyte Medical Systems, Inc. · ARTERIOCYTE MEDICAL SYSTEMS, INC.

FDA 510(k) clearances by year

12013 · K132905

FDA listed device types

showing 8 of 10

Filler, Bone Void, Calcium Compound 1Biopsy Needle 1Instrument, Biopsy 1Set, Blood Transfusion 1Syringe, Piston 1Platelet And Plasma Separator For Bone Graft Handling 1Orthopedic Manual Surgical Instrument 1Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use 1

Market	Identifier	Name	Class / date
US	K132905	200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER	2013-10-04
CA	62477	MAGELLAN AUTOLOGOUS SERUM DISPENSER KIT	Class III

Arteriocyte Medical Systems, 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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