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Deka Research and Development Corporation

USA · Manchester

✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 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

12listed device types

Class I 0Class II 12Class III 0

plus 18 registration records and 28 510(k)

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

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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 States18 registration records, 28 510(k), 0 PMA, 2 excluded

Brazil0 confirmed, 2 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: DEKA RESEARCH & DEVELOPMENT CORP.

FDA 510(k) clearances by year

21984

11986

22011

12013

12015

12016

12018

12019

22020

12023

92024

42025

22026

FDA listed device types

showing 8 of 12

Clamp, Tubing, Blood, Automatic 1Insulin Pump Secondary Display 1Wheelchair, Stair Climbing 1Upper Extremity Prosthesis With Multiple Simultaneous Degrees Of Freedom And Controlled Via Cutaneous Electromyography 1Pump, Infusion 1Alternate Controller Enabled Insulin Infusion Pump 1Set, Administration, Intravascular 1Controller, Infusion, Intravascular, Electronic 1

Market	Identifier	Name	Class / date
US	K261672	twiist Automated Insulin Delivery (AID) System	2026-06-17
US	K261530	iiSure Infusion Set	2026-06-03
US	K243841	Sparta Infusion Set for Insulin	2025-08-01

Deka Research and Development Corporation

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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