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BrainCapture ApS

Denmark · Kongens Lyngby · www.braincapture.dk

✓ Record-verifiedregistrations found in 3 marketsEU SRN DK-MF-000022985

This company has registrations in European Union, United Kingdom, Singapore — 3 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

23UDI-DI device records

Class I 22Class IIa 1

USUnited StatesFDA openFDA

0listed device types

Class I 0Class II 0Class III 0

plus 0 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

2registered device records

Class I 1Custom-made - Class IIa 1

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

1device registrations

CLASS B 1

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.

European Union23 raw hits, 0 excluded, 23 confirmed

United Kingdom2 confirmed, 0 excluded

Regulatory identity

EU manufacturer SRN: DK-MF-000022985
UK responsible person: Prospect Diagnostics Ltd

Registration details (sample)

Market	Identifier	Name	Class / date
EU	05744004470227	BC-Cap Saline	Class I
EU	05744004470210	BC-Cap Saline	Class I
EU	05744004470203	BC-Cap Saline	Class I
EU	05744004470197	BC-Cap Saline	Class I
UK	11467	BrainCapture	Custom-made - Class IIa
UK	63131	BC-Cap Child	Class I

BrainCapture ApS

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Registration details (sample)

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