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AKTORmed GmbH

Germany · Neutraubling · www.aktormed.com

✓ Record-verifiedregistrations found in 8 marketsEU SRN DE-PR-000053838

This company has registrations in European Union, United States, Brazil, Taiwan, South Korea, Australia, Israel, 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

51UDI-DI device records

Class I 51

USUnited StatesFDA openFDA

5listed device types

Class I 0Class II 5Class III 0

plus 6 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

2registered devices

Class II 2

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

2valid device licences

Class I 1Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

2active ARTG entries

Class I 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

2active registrations

Class 1 1Class 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 Union51 raw hits, 0 excluded, 51 confirmed

United States6 registration records, 5 510(k), 0 PMA

Brazil2 confirmed, 0 excluded

Manufacturer names merged into this page: AKTORmed GmbH · AKTORMED GMBH

Regulatory identity

EU manufacturer SRN: DE-PR-000053838
Exhibition record: CMEF 93rd (Apr 2026, Shanghai)

FDA 510(k) clearances by year

12018 · K171947

12020 · K200473

22024 · K233312

12026 · K261573

FDA listed device types

Software Controlled Endoscope And Instrument Holder 1System, Surgical, Computer Controlled Instrument 1Drape, Surgical, Exempt 1Endoscope Holder 1Drape, Surgical, Antimicrobial 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	04260463847048	STERILE SET IIS PU / 10 ea.	Class I
EU	04260463842890	STERILE SET IIS PU / 10 ea.	Class I
EU	04260463848717	JOYSTICK-RH-IIS	Class I
EU	04260463848700	JOYSTICK-LH-IIS	Class I
US	K261573	ENDOSCOPE HOLDER (182214)	2026-07-20
US	K233312	SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894	2024-08-08
US	K232405	ENDOFIX EXO	2024-04-25
BR	10230399002	SOLOASSIST II	Class II
BR	10230399003	ENDOFIX EXO	Class II