Home›Denmark›Ellipse A/S

Ellipse A/S

Denmark · Hoersholm

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Israel, Russia — 4 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

pendingnot queried

USUnited StatesFDA openFDA

7510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

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

5active device licences

Class III 5

6 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

3active registrations

Class 2a 3

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.

United States0 registration records, 7 510(k), 0 PMA, 2 excluded

Canada5 confirmed, 0 excluded

Manufacturer names merged into this page: ELLIPSE A/S

Registration details (sample)

Market	Identifier	Name	Class / date
US	K192951	Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun	2020-03-26
US	K180406	Ellipse Ydun	2018-03-15
US	K161162	Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra	2016-09-16
CA	72478	ELLIPSE FLEX PPT INTENSE PULSED LIGHT SYSTEM	Class III
CA	72479	ELLIPSE LIGHT SPT INTENSE PULSED LIGHT SYSTEM	Class III
CA	72480	ELLIPSE I2PL INTENSE PULSED LIGHT SYSTEM	Class III

Ellipse A/S

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

Similar companies