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Datascope Corp.

USA · Fairfield

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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

4listed device types

Class I 1Class II 3Class III 0

plus 25 registration records and 136 510(k), 13 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

3 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

9active device licences

Class II 4Class IV 5

21 including historic records

TWTaiwanTFDA

2valid device licences

Class III 2

SGSingaporeHSA SMDR

7device registrations

CLASS C 2CLASS D 5

KRSouth KoreaMFDS GMP

4GMP quality-system certificates

Import 4

AUAustraliaTGA ARTG

11active ARTG entries

Class I 7Class III 2IIa 1Class Is (sterile) 1

HKHong KongMDACS

1valid listings

Class IV 1

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

3active registrations

Class 2b 1Class 3 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 States25 registration records, 136 510(k), 13 PMA, 2 excluded

Canada9 confirmed, 0 excluded

Manufacturer names merged into this page: Datascope Corp. · Datascope Corp · DATASCOPE CORP.

FDA 510(k) clearances by year

101993

31994

21995

21996

41997

41998

11999

62000

12001

32002

42003

42004

12005

12006

42007

12013

12015

22017

12018

12019

FDA listed device types

Wire, Guide, Catheter 1System, Balloon, Intra-Aortic And Control 1Introducer, Catheter 1Device, Intravascular Catheter Securement 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K190884	TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool	2019-12-26
US	K181122	CARDIOSAVE Intra-Aortic Balloon Pump	2018-05-31
US	K172305	CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump	2017-10-12
CA	60919	INTRODUCER SET	Class II
CA	60920	GUIDE WIRES - STAINLESS STEEL	Class II
CA	14348	PERCOR STAT-DL INTRA-AORTIC BALLOON CATHETERS	Class IV