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Biosensors Europe SA

Switzerland · Morges · www.biosensors.com

✓ Record-verifiedregistrations found in 7 marketsEU SRN CH-MF-000015764

This company has registrations in European Union, United Kingdom, Brazil, Singapore, Hong Kong, Israel, Russia — 7 overseas markets. EU UDI-DI records ≥294, the first 300 verified individually. 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

≥294UDI-DI device records

Class III 294

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

0listed device types

Class I 0Class II 0Class III 0

plus 0 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

5registered device records

Class III 5

BRBrazilANVISA

0registered devices

7 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

7device registrations

CLASS D 2D WITH MEDICINAL PRODUCT 5

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

3valid listings

Class IV 3

ILIsraelAMAR

8registrations

RURussiaRoszdravnadzor

6active registrations

Class 3 6

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 Union449 raw hits, 6 excluded, 294 confirmed. Large result set — only the first 300 verified

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

United Kingdom5 confirmed, 1 excluded

Brazil0 confirmed, 1 excluded

Canada0 confirmed, 2 excluded

Manufacturer names merged into this page: BIOSENSORS EUROPE SA

Regulatory identity

EU manufacturer SRN: CH-MF-000015764
EU authorised representative: NVT GmbH
UK responsible person: BIOSENSORS INTERNATIONAL UK LTD

Registration details (sample)

Market	Identifier	Name	Class / date
EU	08888893025179	RISE NC Non-Compliant PTCA Balloon Catheter	Class III
EU	08888893025162	RISE NC Non-Compliant PTCA Balloon Catheter	Class III
EU	08888893025155	RISE NC Non-Compliant PTCA Balloon Catheter	Class III
EU	08888893025148	RISE NC Non-Compliant PTCA Balloon Catheter	Class III
UK	47732	RISE NC	Class III
UK	47732	RISE SC Semi-Compliant PTCA Balloon Catheter	Class III
UK	62301	BioFreedom	Class III

Biosensors Europe SA

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Registration details (sample)

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