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NUNC A/S

Denmark · Roskilde
✓ 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
2listed device types
Class I 1Class II 1Class III 0
plus 2 registration records and 2 510(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
2active device licences
Class II 2
4 including historic records
TWTaiwanTFDA
3valid device licences
Class II 3
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
2active ARTG entries
IVD Class 1 1IIa 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
2active registrations
Class 1 2
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 States2 registration records, 2 510(k), 0 PMA, 3 excluded
Brazil0 confirmed, 1 excluded
Canada2 confirmed, 0 excluded
Manufacturer names merged into this page: NUNC A/S

Company information

Country
Denmark
City
Roskilde

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

12004 · K040717
12007 · K070047

FDA listed device types

Labware, Assisted Reproduction, Exempt 1Container, Specimen, Sterile 1

Registration details (sample)

MarketIdentifierNameClass / date
USK070047NUNC IVF DISHES AND NUNC IVF 4-WELL DISH2007-05-18
USK040717NUNC IVF MULTIDISH 4 WELLS NUNCLON2004-08-12
CA90674IVF CENTRIFUGE TUBEClass II
CA90675IVF CRYOTUBEClass II

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