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DEVICOR MEDICAL PRODUCTS, INC.

USA · Cincinnati

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel — 8 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

8listed device types

Class I 3Class II 5Class III 0

plus 61 registration records and 16 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

14registered devices

Class I 2Class II 12

17 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

2active device licences

Class III 2

11 including historic records

TWTaiwanTFDA

3valid device licences

Class I 2Class II 1

SGSingaporeHSA SMDR

7device registrations

CLASS B 2CLASS D 5

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

10active ARTG entries

Class I 2Class III 2IIa 3IIb 1Class Is (sterile) 2

HKHong KongMDACS

3valid listings

Class II 2Class IV 1

ILIsraelAMAR

11registrations

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 States61 registration records, 16 510(k), 0 PMA

Brazil14 confirmed, 0 excluded

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: Devicor Medical Products de Mexico S de RL de CV · Devicor Medical Products, Inc. Warehouse/Distribution/Service Center · DEVICOR MEDICAL PRODUCTS, INC. · DEVICOR MEDICAL PRODUCTS INC.

FDA 510(k) clearances by year

22012

32016

12017

22020

12021

12022

12023

32024

22026

FDA listed device types

Instrument, Biopsy 1System, Imaging, Pulsed Doppler, Ultrasonic 1Drape, Surgical, Exempt 1Marker, Radiographic, Implantable 1Clip, Implantable 1Forceps, General & Plastic Surgery 1Tray, Biopsy, Without Biopsy Instruments 1Probe, Uptake, Nuclear 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260365	Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Foot Switch; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Reusable Tray; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Battery Char	2026-03-04
US	K253761	HydroMARK Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape)	2026-01-23
US	K243095	Mammotome AutoCore Single Insertion Core Biopsy System	2024-10-29
BR	81655639026	Sistema de biópsia assistida a vácuo duplo	Class II
BR	81655639002	Sondas mammotome elite	Class II
BR	81655639004	Sistema de Biópsia Assistida a Vácuo Portátil	Class II
CA	69195	MICROMARK II TISSUE MARKERS WITH INTRODUCER AND APPLIER	Class III
CA	75766	MAMMOTEST BIOPSY SYSTEM	Class III

DEVICOR MEDICAL PRODUCTS, 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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