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Home›Denmark›DGS DIAGNOSTICS A/S

DGS DIAGNOSTICS A/S

Denmark · Middelfart
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Saudi Arabia, Canada, Australia — 4 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
26listed device types
Class I 11Class II 14Class III 0unclassified 1
plus 72 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
18registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
7 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
8active ARTG entries
Class I 5IIa 3
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 States72 registration records, 0 510(k), 0 PMA
Brazil0 confirmed, 1 excluded
Saudi Arabia18 confirmed, 0 excluded
Manufacturer names merged into this page: DGS Diagnostics Sp. z o.o · DGS DIAGNOSTICS A/S · DGS Diagnostic A/S · DGS Diagnostic A/C · DGS Diagnostics A/S
Same-named companies — This database also contains companies with near-identical names: DGS Diagnostics Sp. z o.o. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Denmark
City
Middelfart

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 listed device types

showing 8 of 26
Instrument, Ent Manual Surgical 1Stimulator, Caloric-Water 1Stimulator, Caloric-Air 1Set, Audiometer Calibration 1Syringe, Ent 1Speculum, Ent 1Curette, Ear 1Forceps, Ent 1

Registration details (sample)

MarketIdentifierNameClass / date
SAME0000006933SFDAA00001Disposables Snap Electrodes—
SAME0000006933SFDAA00003Sanibel Probe tubes—

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