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Biodex Medical Systems, Inc.

USA · Shirley

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Israel, Russia — 9 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

9510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 9 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class I 2Class II 2

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

11active device licences

Class II 11

TWTaiwanTFDA

6valid device licences

Class I 4Class II 2

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

6active ARTG entries

Class I 5IIa 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

9registrations

RURussiaRoszdravnadzor

5active registrations

Class 2a 5

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 States0 registration records, 9 510(k), 0 PMA, 1 excluded

Brazil4 confirmed, 0 excluded

Canada11 confirmed, 0 excluded

Manufacturer names merged into this page: BIODEX MEDICAL SYSTEMS INC. · BIODEX MEDICAL SYSTEMS, INC.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K090296	ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336	2009-02-19
US	K063666	SHARPS CONTAINER, MODEL 039-413	2007-01-25
US	K951770	BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP	1995-11-16
BR	80211579014	UNWEIGHING SYSTEM	Class I
BR	10314290021	BIODEX SYSTEM	Class II
BR	10314290040	BIODEX SYSTEM	Class II
CA	1560	XENON - 133 REBREATHING SYSTEM	Class II
CA	1561	FLOOD PHANTOM	Class II
CA	1562	ATOMLAB DOSE CALIBRATOR	Class II

Biodex Medical Systems, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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