HomeGermanyHEINZ KURZ GMBH

HEINZ KURZ GMBH

Germany · Dusslingen
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Australia, Hong Kong — 7 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
11listed device types
Class I 7Class II 4Class III 0
plus 21 registration records and 19 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
3registered devices
Class II 3
5 including historic records
SASaudi ArabiaSFDA
12registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
3 including historic records
TWTaiwanTFDA
1valid device licences
Class I 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
5active ARTG entries
Class I 1IIb 3Class Im (measuring) 1
HKHong KongMDACS
1valid listings
Class III 1
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 States21 registration records, 19 510(k), 0 PMA
Brazil3 confirmed, 0 excluded
Saudi Arabia12 confirmed, 0 excluded
Manufacturer names merged into this page: HEINZ KURZ GMBH MEDIZINTECHNIK · HEINZ KURZ GMBH · Heinz Kurz GmbH Medizintechnik
Same-named companies — This database also contains companies with near-identical names: HEINZ KURZ GMBH MEDIZINTECHNIK. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Germany
City
Dusslingen

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

41997
31999
32000
32001
12002
22004
12007
22013

FDA listed device types

showing 8 of 11
Replacement, Ossicular Prosthesis, Total 1Weights, Eyelid, External 1Prosthesis, Partial Ossicular Replacement 1Tube, Tympanostomy 1Instrument, Ent Manual Surgical 1Gauge, Measuring 1Blade, Scalpel 1Forceps, Ent 1

Registration details (sample)

MarketIdentifierNameClass / date
USK130512NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESIS2013-12-02
USK112616NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESIS2013-02-08
USK071150TROCAR VENTILATION TUBE/WITH TROCAR TIP, TROCAR HANDLE, MODEL 1015 074, 1015 076, 1015 075, 1015 077, W/ RETENTION WIRE2007-12-12
BR81743349003instrumentais cirurgicos para sistema ttp-variacClass II
BR81743349002Instrumentais Cirúrgicos KurzClass II
BR81743349004instrumentais cirurgicos para timpanoplastiaClass II
SAME0000006535SFDAA00027Kurz Precise Cartilage Knife set
SAME0000006535SFDAA00028Cartilage Punch

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