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Capenergy Medical, S.L.

Spain · Sant Joan Despi · www.capenergy.com

✓ Record-verifiedregistrations found in 6 marketsEU SRN ES-MF-000000877

This company has registrations in European Union, United States, United Kingdom, Brazil, Taiwan, Australia — 6 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

7UDI-DI device records

Class IIa 7

USUnited StatesFDA openFDA

2listed device types

Class I 0Class II 2Class III 0

plus 2 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

1registered device records

Class IIa 1

BRBrazilANVISA

1registered devices

Class II 1

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

1valid device licences

Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IIa 1

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 Union7 raw hits, 0 excluded, 7 confirmed

United States2 registration records, 3 510(k), 0 PMA

United Kingdom1 confirmed, 0 excluded

Brazil1 confirmed, 0 excluded

Manufacturer names merged into this page: CAPENERGY MEDICAL, S.L.

Regulatory identity

EU manufacturer SRN: ES-MF-000000877
UK responsible person: CMC Medical Devices LTD

Registration details (sample)

Market	Identifier	Name	Class / date
EU	08437021499063	C500	Class IIa
EU	08437021499056	C400	Class IIa
EU	08437021499049	C300	Class IIa
EU	08437021499032	C200	Class IIa
UK	47575	Capenergy	Class IIa
US	K253480	Capenergy C Equipments RF C200 and C400 Drakarian	2026-07-10
US	K222260	Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500	2023-03-28
US	K191202	CAPENERGY - C100, C200, C300, C400, C50	2020-02-11
BR	80341949007	Família de Equipamentos de Radiofrequência e Tecarterapia CAPENERGY	Class II

Capenergy Medical, S.L.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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