HomeNetherlandsKONINKLIJKE UTERMOHLEN N.V.

KONINKLIJKE UTERMOHLEN N.V.

Netherlands · Wolvega
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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
1listed device types
Class I 0Class II 1Class III 0
plus 3 registration records and 3 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class II 2
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
5active device licences
Class II 5
7 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
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 States3 registration records, 3 510(k), 0 PMA
Brazil2 confirmed, 0 excluded
Canada5 confirmed, 0 excluded
Manufacturer names merged into this page: KONINKLIJKE (ROYAL) UTERMOHLEN N.V. · KONINKLIJKE UTERMOHLEN N.V. · KONINKLIJKE (ROYAL) UTERMOHLEN NV
Same-named companies — This database also contains companies with near-identical names: KONINKLIJKE (ROYAL) UTERMOHLEN NV, Koninklijke Utermohlen NV. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Netherlands
City
Wolvega

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

12011 · K101049
12013 · K130599
12015 · K152203

FDA listed device types

Unit, Cryosurgical, Accessories 1

Registration details (sample)

MarketIdentifierNameClass / date
USK152203UTERMOHLEN CRYO PROFESSIONAL2015-11-06
USK130599WART FREEZE2013-06-05
USK101049WART FREEZE2011-06-23
BR80117580838ADEUS VERRUGASClass II
BR80117589156HeltiQ Skin TagsClass II
CA82158WART FREEZEClass II
CA93602WART FREEZERClass II
CA93626SKIN TAGSClass II

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