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Senorx, Inc.

USA · Tempe

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Hong Kong, 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

30510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 30 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

8registered devices

Class I 3Class II 5

12 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

6active device licences

Class II 3Class III 3

14 including historic records

TWTaiwanTFDA

12valid device licences

Class I 2Class II 10

SGSingaporeHSA SMDR

6device registrations

CLASS B 3CLASS D 3

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

6active ARTG entries

Class III 4IIa 1IIb 1

HKHong KongMDACS

3valid listings

Class II 1Class III 1Class IV 1

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

1active registrations

Class 2a 1

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, 30 510(k), 0 PMA

Brazil8 confirmed, 0 excluded

Canada6 confirmed, 0 excluded

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

Registration details (sample)

Market	Identifier	Name	Class / date
US	K233220	EnCor EnspireBreast Biopsy System (E4115, E4230); EnCor Breast Biopsy Driver (DRENCOR); EnCor MRI Breast Biopsy Driver (DRENCORMR); EnCor Breast Biopsy Driver Probes (ECP017G, ECP017GV, ECP0110G, ECP0110GV, ECP0112G, ECP0112GV); EnCor MRI Breast Biopsy Probes (ECPMR017G, ECPMR0110G, ECPMR0110GBT)	2023-10-27
US	K210654	EnCor Breast Biopsy Probe with Rinse Tube	2021-03-31
US	K161805	EnCor MRI Introducer Set, EnCor Probe Introducer	2016-07-19
BR	80689090010	EnCor Enspire - Equipamento para biópsia de mama	Class II
BR	80689099004	EnCor Probe	Class II
BR	80689099009	EnCor Probe Upright	Class II
CA	80776	SENOSONIX ULTRASOUND BREAST BIOPSY SYSTEM	Class III
CA	26881	ANCHOR GUIDE WITH EASY GUIDE TIP	Class II
CA	27048	EASY GUIDE RADIOFREQUENCY ACCESS DEVICE	Class II

Senorx, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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