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Home›Sweden›NIDACON INTERNATIONAL AB

NIDACON INTERNATIONAL AB

Sweden · Molndal
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Canada, Taiwan, Australia, Russia — 5 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
3listed device types
Class I 1Class II 2Class III 0
plus 11 registration records and 12 510(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
4active device licences
Class II 4
24 including historic records
TWTaiwanTFDA
2valid device licences
Class I 1Class II 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
5active ARTG entries
IVD Class 1 1IIa 4
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
1active registrations
Class 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 States11 registration records, 12 510(k), 0 PMA
Canada4 confirmed, 0 excluded
Manufacturer names merged into this page: NIDACON INTERNATIONAL AB

Company information

Country
Sweden
City
Molndal

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

11998
11999
22000
42001
22002
12010
12014

FDA listed device types

Eosin Y 1Media, Reproductive 1Labware, Assisted Reproduction 1

Registration details (sample)

MarketIdentifierNameClass / date
USK131145PROINSERT2014-02-20
USK092107VITRIBLAST, THERMOBLAST, MODEL VB-010, TB-0102010-06-15
USK023206SPERM CRYOPROTEC2002-11-08
CA90PURESPERMClass II
CA66334READYSWIMClass II
CA66337SPERMASSISTClass II

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