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TensCare Europe B.V

Netherlands · Heerhugowaard · www.tenscare.co.uk

✓ Record-verifiedregistrations found in 2 marketsEU SRN UK-PR-000039358

This company has registrations in European Union, United Kingdom — 2 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

89UDI-DI device records

Class I 39Class IIa 50

USUnited StatesFDA openFDA

0listed device types

Class I 0Class II 0Class III 0

plus 0 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

7registered device records

Class I 3Class IIa 4

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 Union89 raw hits, 0 excluded, 89 confirmed

United States0 registration records, 0 510(k), 0 PMA, 2 excluded

United Kingdom7 confirmed, 0 excluded

Canada0 confirmed, 1 excluded

Regulatory identity

EU manufacturer SRN: UK-PR-000039358
EU authorised representative: Advena Limited

Registration details (sample)

Market	Identifier	Name	Class / date
EU	05033435132966	Perfect PFE for men	Class IIa
EU	05033435132768	Pelvi+	Class IIa
EU	05033435138784	50x100mm Cool Relief Electrodes	Class I
EU	05033435138777	50x50mm Cool Relief Electrodes	Class I
UK	35372	Mynd	Class IIa
UK	47790	Shockwave	Class I
UK	36050	Gold Vaginal Probe with Gold plated rings	Class IIa

TensCare Europe B.V

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Registration details (sample)

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