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BLUE MEDICAL DEVICES BV

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Taiwan, Singapore, South Korea, Hong Kong, Israel, Russia — 8 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

1listed device types

Class I 1Class II 0Class III 0

plus 1 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

153registered devices

Class I 1Class II 152

156 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

4valid device licences

Class II 4

SGSingaporeHSA SMDR

1device registrations

D WITH MEDICINAL PRODUCT 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

4valid listings

Class IV 4

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

1active registrations

Class 3 1

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 States1 registration records, 0 510(k), 0 PMA, 59 excluded

Brazil153 confirmed, 15 excluded

Saudi Arabia0 confirmed, 12 excluded

Canada0 confirmed, 7 excluded

Manufacturer names merged into this page: BLUE MEDICAL BV · BLUE NEEM MEDICAL DEVICES PRIVATE LIMITED · BLUE MEDICAL DEVICE BV · BLUE NEEM MEDICAL DEVICES PVT.LTD · BLUE NEEM MEDICAL DEVICES PVT LTD

Registration details (sample)

Market	Identifier	Name	Class / date
BR	80076809043	WortX URETERAL ACCESS SHEATH WITH SUCTION	Class II
BR	81189660024	Cateter Ureteral Radiopaco	Class II
BR	81189660025	Cateter Ureteral Hidrofílico Radiopaco Duas Pontas Abertas	Class II

BLUE MEDICAL DEVICES BV

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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