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DAS MEDICAL INTERNATIONAL, SRL

Dominican Republic · La Romana La Romana

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, Taiwan, 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

20listed device types

Class I 8Class II 12Class III 0

plus 34 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

3 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

4active device licences

Class II 2Class III 2

40 including historic records

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

Class Is (sterile) 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States34 registration records, 6 510(k), 0 PMA, 69 excluded

Brazil1 confirmed, 204 excluded

Saudi Arabia0 confirmed, 120 excluded

Canada4 confirmed, 192 excluded

Manufacturer names merged into this page: BEST MEDICAL INTERNATIONAL, INC. · DAS MEDICAL INTERNATIONAL, SRL · MEDITECH INTERNATIONAL INC. · BEST MEDICAL INTERNATIONAL, INC · Best Medical International, Inc.

FDA 510(k) clearances by year

32004 · K043117

12006 · K061638

12013 · K132097

12018 · K162499

FDA listed device types

showing 8 of 20

System, Applicator, Radionuclide, Remote-Controlled 1Transducer, Ultrasonic, Diagnostic 1System, Imaging, Pulsed Echo, Ultrasonic 1System, Surgical, Computer Controlled Instrument 1Drape, Surgical, Exempt 1Source, Isotope, Sealed, Gold, Titanium, Platinum 1System, X-Ray, Angiographic 1Drape, Urological, Disposable 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K162499	Best Instruminal Applicator	2018-04-13
US	K132097	BEST MULTI-LUMEN BALLOON APPLICATOR FOR BRACHYTHERAPY	2013-09-30
US	K061638	BEST STRAND AND BEST SPACER	2006-08-04
BR	80047309168	AGULHAS DE AÇO INOXIDÁVEL PARA BRAQUITERAPIA E IMPLANTES BEST®	Class II
CA	30370	IRIDIUM 192 IN NYLON RIBBONS	Class III
CA	30372	GOLD 198	Class III
CA	33322	DISPOSABLE RUBBER SLEEVES	Class II

DAS MEDICAL INTERNATIONAL, SRL

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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