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Vitrolife, Inc.

USA · San Diego

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, Taiwan, South Korea, Australia — 6 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

6listed device types

Class I 2Class II 4Class III 0

plus 22 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class II 2

3 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

1active device licences

Class II 1

2 including historic records

TWTaiwanTFDA

2valid device licences

Class II 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

2active ARTG entries

IVD Class 1 1IIa 1

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.

United States22 registration records, 5 510(k), 0 PMA, 5 excluded

Brazil2 confirmed, 3 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada1 confirmed, 2 excluded

Manufacturer names merged into this page: Vitrolife Inc. · Vitrolife GmbH · VITROLIFE INC. · VITROLIFE GMBH · VITROLIFE INC

FDA 510(k) clearances by year

12003 · K022730

22004 · K032155

12014 · K133568

12020 · K192008

FDA listed device types

Radioimmunoassay, Luteinizing Hormone 1Hemocytometer 1Media, Reproductive 1Microtools, Assisted Reproduction (Pipettes), Exempt 1System, Assisted Reproduction Laser 1Media, Reproductive, Exempt 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K192008	LaserShot M, NaviLase	2020-03-25
US	K133568	G-TL	2014-07-16
US	K032155	G-THAWKIT BLAST	2004-05-07
BR	83085839001	Octax Laser	Class II
BR	82592939011	Octax Laser	Class II
CA	68576	OVULATION TEST KIT	Class II

Vitrolife, Inc.

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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