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DEFIBTECH, LLC

USA · Guilford

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Canada, Singapore, South Korea, Australia, Hong Kong, Israel — 7 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

2listed device types

Class I 0Class II 1Class III 1

plus 6 registration records and 9 510(k), 17 PMA

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 II 1

8 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

4device registrations

CLASS C 4

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

5active ARTG entries

IIb 5

HKHong KongMDACS

1valid listings

Class III 1

ILIsraelAMAR

6registrations

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 States6 registration records, 9 510(k), 17 PMA, 1 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: DEFIBTECH LLC · DEFIBTECH, LLC

Registration details (sample)

Market	Identifier	Name	Class / date
US	K211289	RMU-2000 Automated Chest Compression System	2021-11-09
US	K141809	RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEM	2014-10-27
US	K131525	SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES	2014-04-24
CA	82815	DDU-100 SERIES DEFIBRILLATION ELECTRODE ADAPTER	Class II

DEFIBTECH, LLC

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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