Home›Flen Health N.V.

Flen Health N.V.

✓ Record-verifiedregistrations found in 8 marketsEU SRN BE-MF-000000258

This company has registrations in European Union, United Kingdom, Brazil, Taiwan, Singapore, Australia, Hong Kong, Israel — 8 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

3UDI-DI device records

Class IIa 1Class IIb 2

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 IIa 1Class IIb 1

BRBrazilANVISA

2registered devices

Class II 2

4 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

2valid device licences

Class I 1Class II 1

SGSingaporeHSA SMDR

2device registrations

CLASS B 1CLASS C 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

IIa 1IIb 2

HKHong KongMDACS

3valid listings

Class II 1Class III 2

ILIsraelAMAR

4registrations

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 Union3 raw hits, 0 excluded, 3 confirmed

United Kingdom2 confirmed, 0 excluded

Brazil2 confirmed, 0 excluded

Manufacturer names merged into this page: FLEN HEALTH NV

Regulatory identity

EU manufacturer SRN: BE-MF-000000258
UK responsible person: Flen Health UK LTD
Exhibition record: CMEF 89th (Apr 2024, Shanghai)

Registration details (sample)

Market	Identifier	Name	Class / date
EU	05420013500482	—	Class IIa
EU	05420013502868	—	Class IIb
EU	05420013502875	—	Class IIb
UK	47474	Flaminal Forte	Class IIb
UK	47764	Flamigel	Class IIa
BR	81706719003	FlamiActiv	Class II
BR	81706719001	FlamiActiv RT	Class II

Flen Health N.V.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Registration details (sample)

Similar companies