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Caesarea Medical Electronics , Ltd.

Israel · Caesarea

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Canada, Singapore, Australia, Hong Kong, Russia — 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

9510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 9 510(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 3Class III 4

14 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

4device registrations

CLASS B 2CLASS C 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

6active ARTG entries

Class I 2IIa 2IIb 2

HKHong KongMDACS

3valid listings

Class II 2Class III 1

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

3active registrations

Class 2a 1Class 2b 2

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 States0 registration records, 9 510(k), 0 PMA

Canada7 confirmed, 0 excluded

Manufacturer names merged into this page: CAESAREA MEDICAL ELECTRONICS LTD.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K080954	T34L SYRINGE DRIVER	2008-05-16
US	K070235	BODYGUARD PAIN MANAGER INFUSION SYSTEM	2007-05-18
US	K070718	MODIFICATION TO: BODYGUARD INFUSION SYSTEM	2007-04-13
CA	62366	BODYGUARD 323 IV INFUSION PUMP	Class III
CA	82130	PUMP EXTERNAL CHARGER	Class II
CA	82131	NEOFEED ENTERAL FEEDING SYRINGE PUMP	Class II

Caesarea Medical Electronics , Ltd.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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