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Home›Slovenia›Domel, d.o.o.

Domel, d.o.o.

Slovenia · Zelezniki · labs.domel.com
✓ Record-verifiedregistrations found in 2 marketsEU SRN SI-MF-000030074

This company has registrations in European Union, Russia — 2 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
12UDI-DI device records
IVD A 12
USUnited StatesFDA openFDA
0listed device types
Class I 0Class II 0Class III 0
plus 0 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
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
0active device licences
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
1active registrations
Class 2a 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.

European Union12 raw hits, 0 excluded, 12 confirmed
United States0 registration records, 0 510(k), 0 PMA, 1 excluded

Regulatory identity

EU manufacturer SRN
SI-MF-000030074

Company information

Country
Slovenia
City
Zelezniki
Website
labs.domel.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesLaboratory, IVD & DiagnosticsLaboratory automation & robotics

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.

Registration details (sample)

MarketIdentifierNameClass / date
EU03830083230127CENTRIC MF 48 R IVDIVD A
EU03830083230110CENTRIC MF 48 R IVDIVD A
EU03830083230103CENTRIC MF 48 IVDIVD A
EU03830083230097CENTRIC MF 48 IVDIVD A

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