HomeGermanySolventum Germany GmbH

Solventum Germany GmbH

Germany · Kamen
✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel — 8 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
43listed device types
Class I 26Class II 14Class III 0unclassified 3
plus 181 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
7registered devices
Class I 1Class II 6
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
0active device licences
15 including historic records
TWTaiwanTFDA
2valid device licences
Class I 2
SGSingaporeHSA SMDR
7device registrations
CLASS B 5CLASS D 2
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
33active ARTG entries
Class I 13Class III 4IIa 9IIb 5Class Is (sterile) 2
HKHong KongMDACS
11valid listings
Class II 4Class III 4Class IV 3
ILIsraelAMAR
9registrations
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 States181 registration records, 1 510(k), 0 PMA, 8 excluded
Brazil7 confirmed, 2 excluded
Canada0 confirmed, 2 excluded
Manufacturer names merged into this page: Solventum Germany GmbH · SOLVENTUM GERMANY GMBH

Company information

Country
Germany
City
Kamen

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

12026 · K251999

FDA listed device types

showing 8 of 43
Activator, Ultraviolet, For Polymerization 1Cement, Dental 1Negative Pressure Wound Therapy Powered Suction Pump 1Alloy, Metal, Base 1Liner, Cavity, Calcium Hydroxide 1Material, Tooth Shade, Resin 1Material, Impression 1System, Thermal Regulating 1

Registration details (sample)

MarketIdentifierNameClass / date
USK251999Promogran Prisma™ Collagen Matrix with ORC and Silver2026-03-13
BR83255939033Solventum RelyX Cimento Provisório sem EugenolClass II
BR83255939038Solventum Protemp 4Class II
BR83255939049Solventum RelyX UniversalClass II

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