Home›Sweden›VITROLIFE SWEDEN AB

VITROLIFE SWEDEN AB

Sweden · Vastra Frolunda

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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

10listed device types

Class I 1Class II 9Class III 0

plus 32 registration records and 38 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

17registered devices

Class I 2Class II 15

46 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

8active device licences

Class II 8

50 including historic records

TWTaiwanTFDA

10valid device licences

Class II 10

SGSingaporeHSA SMDR

33device registrations

CLASS B 7CLASS C 3CLASS D 23

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

48active ARTG entries

Class I 1Class III 26IVD Class 1 1IIa 13IIb 1Class Is (sterile) 6

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

4registrations

RURussiaRoszdravnadzor

3active registrations

Class 2a 2Class 3 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.

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 States32 registration records, 38 510(k), 0 PMA, 8 excluded

Brazil17 confirmed, 4 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada8 confirmed, 2 excluded

Manufacturer names merged into this page: VITROLIFE SWEDEN AB

FDA 510(k) clearances by year

42000

12001

92002

12003

22004

12005

62008

22009

12010

12012

12014

12015

22017

22019

12021

22024

12025

FDA listed device types

showing 8 of 10

Needle, Assisted Reproduction 1Media, Reproductive, Exempt 1Catheter, Assisted Reproduction 1Transducer, Ultrasonic, Diagnostic 1Media, Reproductive 1Microtools, Assisted Reproduction (Pipettes), Exempt 1Tubing, Noninvasive 1Labware, Assisted Reproduction 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K243373	Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500); EmbryoCath Embryo Transfer Catheter - Straight Malleable 180 mm (REF 17501); EmbryoCath Embryo Transfer Catheter - Straight Malleable 230 mm (REF 17502); EmbryoCath Stylet - 180 mm (REF 17510); EmbryoCath Stylet - 230 mm (REF 17511)	2025-07-23
US	K241662	Ultrasound Transducer Cover	2024-08-30
US	K240605	Ultra RapidWarm Blast	2024-08-07
BR	82592930037	Ultrasound Transducer Cover	Class I
BR	83085839003	Ovoil Heavy	Class II
BR	83085839004	Ovoil	Class II
CA	66155	G-1 V5	Class II
CA	66156	G- FREEZEKIT BLAST	Class II
CA	66158	G-2 V5	Class II