HomeGermanyDMG – CHEMISCH-PHARMAZEUTISCHE FABRIK GMBH

DMG – CHEMISCH-PHARMAZEUTISCHE FABRIK GMBH

Germany · Hamburg
✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Russia — 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
19listed device types
Class I 10Class II 9Class III 0
plus 38 registration records and 4 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
31registered devices
Class I 10Class II 21
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
6active device licences
Class II 3Class III 3
35 including historic records
TWTaiwanTFDA
15valid device licences
Class I 5Class II 10
SGSingaporeHSA SMDR
9device registrations
CLASS B 9
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
30active ARTG entries
Class I 12IIa 18
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
17active registrations
Class 1 1Class 2a 16
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 States38 registration records, 4 510(k), 0 PMA
Brazil31 confirmed, 1 excluded
Canada6 confirmed, 0 excluded
Manufacturer names merged into this page: DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH · DR. GERHARD MANN CHEMISCH-PHARMAZEUTISCHE FABRIK GMBH · DMG CHEMISCH-PHARMAZEUTISCHE FABRIK GMBH · DMG CHEMISCH PHARMAUZEUSTISCHE FABRIK GMBH · DMG – CHEMISCH-PHARMAZEUTISCHE FABRIK GMBH · DMG CHEMISCH-PHARMAZEUSTISCHE FABRIK GMBH

Company information

Country
Germany
City
Hamburg

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

11994 · K924830
11999 · K991172
12019 · K183337
12022 · K213201

FDA listed device types

showing 8 of 19
Sealant, Pit And Fissure, And Conditioner 1Cement, Dental 1Resin, Denture, Relining, Repairing, Rebasing 1Material, Tooth Shade, Resin 1Material, Impression 1Crown And Bridge, Temporary, Resin 1Crown And Bridge, Long-Term Temporary, Resin 1Agent, Tooth Bonding, Resin 1

Registration details (sample)

MarketIdentifierNameClass / date
USK213201DeltaFil, DeltaFil Conditioner2022-06-01
USK183337LuxaCrown, Shade A1, A2, A3, A3.5; LuxaCrown B1, B3, C2, D22019-05-29
USK991172IONOSIT BOND1999-05-17
BR10346410093VITIQUEClass II
BR10346410096ICON PROXIMALClass II
BR10346410112ECOSITE BULK FILLClass II
CA66519LUXATEMP GLAZE & BONDClass II
CA74832ETCHING GELClass II
CA74833LUXATEMP INLAYClass II

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