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SISSEL GmbH

Germany · Bad Dürkheim · www.sissel.de

✓ Record-verifiedregistrations found in 3 marketsEU SRN DE-MF-000007624

This company has registrations in European Union, United Kingdom, Taiwan — 3 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

153UDI-DI device records

Class I 153

USUnited StatesFDA openFDA

0listed device types

Class I 0Class II 0Class III 0

plus 0 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

11registered device records

Class I 11

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

2valid device licences

Class I 2

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 Union153 raw hits, 0 excluded, 153 confirmed

United Kingdom11 confirmed, 0 excluded

Regulatory identity

EU manufacturer SRN: DE-MF-000007624
UK responsible person: Sissel UK Ltd

Registration details (sample)

Market	Identifier	Name	Class / date
EU	04250694718323	SISSEL®Traveller C5 incl. cover	Class I
EU	04250694718293	SISSEL®Traveller incl. cover	Class I
EU	04250694702377	SISSEL ® Sit Special beige	Class I
EU	04250694717005	SPINEFITTER by SISSEL® Multi Extension Kit Set of 5	Class I
UK	41158	SISSEL® Securemax ball blue/purple 45cm	Class I
UK	34181	SISSEL® FITBAND ESSENTIAL blue x-strong	Class I
UK	41573	SISSEL® BAMBINI neck pillow incl. cover	Class I

SISSEL GmbH

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Registration details (sample)

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