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Vitrolife A/S

Denmark · Viby J

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Israel, Russia — 9 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

5listed device types

Class I 1Class II 4Class III 0

plus 9 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class II 2

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

3registered imported devices

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

CACanadaMDALL

0active device licences

2 including historic records

TWTaiwanTFDA

2valid device licences

Class II 2

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

4active ARTG entries

Class I 1IIa 3

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

1active registrations

Class 2a 1

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.

Australia, Saudi Arabia, Singapore, Israel: under each source's terms, this site shows record counts and official links only — no record details on pages, in search, in the member area or in exports.

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 States9 registration records, 4 510(k), 0 PMA, 8 excluded

Brazil2 confirmed, 4 excluded

Saudi Arabia3 confirmed, 0 excluded

Canada0 confirmed, 2 excluded

Manufacturer names merged into this page: Vitrolife A/S · VITROLIFE A/S

FDA 510(k) clearances by year

12015 · K150961

12018 · K173264

12019 · K182798

12022 · K213869

FDA listed device types

Embryo Image Assessment System, Assisted Reproduction 1System, Assisted Reproduction Laser 1Accessory, Assisted Reproduction 1Labware, Assisted Reproduction 1Microscope And Microscope Accessories, Reproduction, Assisted 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K213869	EmbryoSlide+ ic8 dish	2022-03-11
US	K182798	KIDScore D3	2019-07-19
US	K173264	EmbryoScope+	2018-05-11
BR	83085839002	Incubadora Sequencial EmbryoScope	Class II
BR	82592939003	Incubadora Sequencial EmbryoScope	Class II

Vitrolife A/S

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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