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BIOGENESIS EUROPA, S.L.

Spain · Badajoz

✓ Record-verifiedregistrations found in 1 marketsEU SRN UY-MF-000002444

This company has registrations in European Union — 1 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

203UDI-DI device records

Class I 202Class IIb 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

0registered device records

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

pendingnot queried

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 Union203 raw hits, 0 excluded, 203 confirmed

United States0 registration records, 0 510(k), 0 PMA, 1 excluded

Brazil0 confirmed, 3 excluded

Regulatory identity

EU manufacturer SRN: UY-MF-000002444
EU authorised representative: CMC Medical Devices & Drugs SL

Registration details (sample)

Market	Identifier	Name	Class / date
EU	07730793200020	Temperature sensor compatible Dräger, skin 9.50mm	Class IIb
EU	07730793005427	ECG cable compatible with Zoll, clamp 4 leads complete	Class I
EU	07730793005434	ECG cable compatible with Zoll, clamp 6 leads complete	Class I
EU	07730793005632	ECG cable compatible with Carewell, clamp 10 leads complete	Class I

BIOGENESIS EUROPA, S.L.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Registration details (sample)

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