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TROKAMED GMBH

Germany · Geisingen

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Australia, Israel — 5 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

22listed device types

Class I 16Class II 6Class III 0

plus 23 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

8registered devices

Class I 3Class II 5

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

7 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

27active ARTG entries

Class I 27

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

4registrations

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 States23 registration records, 4 510(k), 0 PMA

Brazil8 confirmed, 0 excluded

Manufacturer names merged into this page: TROKAMED GMBH

FDA 510(k) clearances by year

22006 · K060233

12011 · K091010

12021 · K200770

FDA listed device types

showing 8 of 22

Forceps, Biopsy, Non-Electric 1Retractor, Non-Self-Retaining 1Forceps 1Instrument, Ligature Passing And Knot Tying 1Probe 1Retractor, Self-Retaining 1Accessories, Arthroscopic 1Hysteroscope Accessories 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K200770	Mini PCNL-System	2021-07-30
US	K091010	TROKAMED MORCELLATOR	2011-03-01
US	K060233	TROKAMED GMBH ENDOSCOPES AND ACCESSORIES	2006-07-19
BR	10368419018	DISPOSITIVO PARA RESSECÇÃO	Class II
BR	80978563763	Instrumentais Reutilizáveis Arthrex IX	Class I
BR	80912390003	INSTRUMENTAL CIRÚRGICO PARA VIDEOCIRURGIA ARTICULADO NÃO CORTANTE DOCT	Class I

TROKAMED GMBH

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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