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Degania Silicone , Ltd.

Israel · Degania Bet

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Canada, Singapore, South Korea, 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

22listed device types

Class I 8Class II 14Class III 0

plus 31 registration records and 19 510(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

7active device licences

Class II 6Class III 1

8 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

1device registrations

CLASS C 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

9active ARTG entries

IIa 2IIb 6Class Is (sterile) 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

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 States31 registration records, 19 510(k), 0 PMA, 1 excluded

Canada7 confirmed, 0 excluded

Manufacturer names merged into this page: DEGANIA SILICONE, LTD. · DEGANIA SILICONE LTD.

FDA 510(k) clearances by year

11988

11992

21995

21997

11998

22007

12011

12012

12013

42014

12016

12024

12026

FDA listed device types

showing 8 of 22

Gastrointestinal Tubes With Enteral Specific Connectors 1Tube, Feeding 1Cystoscope And Accessories, Flexible/Rigid 1Endoscopic Guidewire, Gastroenterology-Urology 1Dilator, Cervical, Hygroscopic-Laminaria 1Percutaneous Replacement Gastrostomy Tube Kit 1Drape, Surgical, Exempt 1Tubes, Gastrointestinal (And Accessories) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K254170	Percutaneous Endoscopic Gastrostomy (PEG) Kit	2026-03-20
US	K233591	Stylus	2024-05-31
US	K152246	Aquarius Stoma Measuring Device	2016-06-21
CA	65844	SILICONE IDENTI LOOPS	Class II
CA	66065	CLOSED WOUND DRAINAGE SYSTEM	Class II
CA	68860	SILICONE DRAIN SETS	Class II

Degania Silicone , Ltd.

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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